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Absorica

isotretinoin · Capsule

Prescription NDA TE AB2 RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Absorica
Generic name
isotretinoin
Dosage form
Capsule
Route
Oral
Marketing category
NDA · NDA
Labeler
Sun Pharmaceutical Industries, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
6
NDC product codes
6
Packages
6
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Isotretinoin 10 mg/1 197843 View
Isotretinoin 20 mg/1 197843 View
Isotretinoin 25 mg/1 197843 View
Isotretinoin 30 mg/1 197843 View
Isotretinoin 35 mg/1 197843 View
Isotretinoin 40 mg/1 197843 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Retinoid [EPC] EPC All 35 members
Retinoids [CS] CS All 35 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021951
Application type
NDA · New Drug Application
Approval date
May 25, 2012
Sponsor
SUN PHARM INDS INC
Products on application
6
Submissions recorded
24
Products approved under application 021951.
Product Trade name Form Strength Ingredient Status TE Flags
021951-001 ABSORICA CAPSULE ISOTRETINOIN Prescription AB2 RLD
021951-002 ABSORICA CAPSULE ISOTRETINOIN Prescription AB2 RLD
021951-003 ABSORICA CAPSULE ISOTRETINOIN Prescription AB2 RLD
021951-004 ABSORICA CAPSULE ISOTRETINOIN Prescription AB2 RLD RS
021951-005 ABSORICA CAPSULE ISOTRETINOIN Prescription AB2 RLD
021951-006 ABSORICA CAPSULE ISOTRETINOIN Prescription AB2 RLD

Therapeutic equivalence

Source: Orange Book
TE code
AB2
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 021951.
Type No. Action Status Date Review
Supplement 31 Labeling Approved August 11, 2026 Standard
Supplement 29 Labeling Approved June 12, 2026 Standard
Supplement 28 REMS Approved February 9, 2026 N/A
Supplement 16 Labeling Approved June 28, 2024 Standard
Supplement 24 Labeling Approved July 18, 2023 Standard
Supplement 23 Labeling Approved July 18, 2023 Standard
Supplement 22 REMS Approved March 24, 2023 N/A
Supplement 21 REMS Approved October 6, 2022 N/A
Supplement 18 REMS Approved October 8, 2021 N/A
Supplement 17 REMS Approved December 9, 2020 N/A
Supplement 15 REMS Approved January 24, 2020 N/A
Supplement 13 Labeling Approved November 7, 2019 Standard
Supplement 14 Labeling Approved August 31, 2018 Standard
Supplement 11 Labeling Approved May 2, 2018 Standard
Supplement 12 REMS Approved April 23, 2018 N/A
Supplement 10 REMS Approved June 17, 2017 N/A
Supplement 8 REMS Approved July 8, 2016 N/A
Supplement 7 REMS Approved February 4, 2016 N/A
Supplement 6 Manufacturing (CMC) Approved December 23, 2015 Standard
Supplement 5 REMS Approved September 3, 2015 N/A
Supplement 4 Manufacturing (CMC) Approved October 20, 2014 Standard
Supplement 3 Manufacturing (CMC) Approved August 15, 2014 Standard
Supplement 1 Labeling Approved July 30, 2014 Unknown
Original application 1 Type 3 - New Dosage Form Approved May 25, 2012 Standard

Review documents

  • 0 · Supplement · August 19, 2026
  • 0 · Supplement · August 14, 2026
  • 0 · Supplement · June 16, 2026
  • 0 · Supplement · June 16, 2026
  • 0 · Supplement · June 16, 2026
  • 0 · Supplement · February 10, 2026
  • 0 · Supplement · August 2, 2024
  • 0 · Supplement · July 2, 2024
  • 0 · Supplement · July 20, 2023
  • 0 · Supplement · July 19, 2023
  • 0 · Supplement · March 27, 2023
  • 0 · Supplement · October 7, 2022
  • 0 · Supplement · October 13, 2021
  • 0 · Supplement · December 10, 2020
  • 0 · Supplement · January 28, 2020
  • 0 · Supplement · November 14, 2019
  • 0 · Supplement · November 14, 2019
  • 0 · Supplement · November 12, 2019
  • 0 · Supplement · September 27, 2018
  • 0 · Supplement · September 13, 2018
  • 0 · Supplement · May 4, 2018
  • 0 · Supplement · May 3, 2018
  • 0 · Supplement · April 24, 2018
  • 0 · Supplement · June 20, 2017
  • 0 · Supplement · July 12, 2016
  • 0 · Supplement · February 5, 2016
  • 0 · Supplement · September 8, 2015
  • 0 · Supplement · September 8, 2015
  • 0 · Supplement · August 20, 2014
  • 0 · Supplement · August 19, 2014

Adverse event reports

Source: openFDA FAERS
49,172
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ISOTRETINOIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
10631-115-31 10631-115 Sun Pharmaceutical Industries, Inc. 3 BLISTER PACK in 1 BOX (10631-115-31) / 10 CAPSULE in 1 BLISTER PACK (10631-115-69) June 8, 2012
10631-116-31 10631-116 Sun Pharmaceutical Industries, Inc. 3 BLISTER PACK in 1 BOX (10631-116-31) / 10 CAPSULE in 1 BLISTER PACK (10631-116-69) June 8, 2012
10631-117-31 10631-117 Sun Pharmaceutical Industries, Inc. 3 BLISTER PACK in 1 BOX (10631-117-31) / 10 CAPSULE in 1 BLISTER PACK (10631-117-69) June 8, 2012
10631-118-31 10631-118 Sun Pharmaceutical Industries, Inc. 3 BLISTER PACK in 1 BOX (10631-118-31) / 10 CAPSULE in 1 BLISTER PACK (10631-118-69) June 8, 2012
10631-133-31 10631-133 Sun Pharmaceutical Industries, Inc. 3 BLISTER PACK in 1 BOX (10631-133-31) / 10 CAPSULE in 1 BLISTER PACK (10631-133-69) February 17, 2015
10631-134-31 10631-134 Sun Pharmaceutical Industries, Inc. 3 BLISTER PACK in 1 BOX (10631-134-31) / 10 CAPSULE in 1 BLISTER PACK (10631-134-69) February 17, 2015
10631-115 10631-115 Sun Pharmaceutical Industries, Inc. — June 8, 2012
10631-116 10631-116 Sun Pharmaceutical Industries, Inc. — June 8, 2012
10631-117 10631-117 Sun Pharmaceutical Industries, Inc. — June 8, 2012
10631-118 10631-118 Sun Pharmaceutical Industries, Inc. — June 8, 2012
10631-133 10631-133 Sun Pharmaceutical Industries, Inc. — February 17, 2015
10631-134 10631-134 Sun Pharmaceutical Industries, Inc. — February 17, 2015

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.