OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

ELIQUIS

apixaban · Kit

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

Overview

Brand name
ELIQUIS 30-Day Starter Pack
Generic name
apixaban
Dosage form
Kit
Route
—
Marketing category
NDA · NDA
Labeler
E.R. Squibb & Sons, L.L.C.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
2
Packages
1
Data completeness
54% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
3

Regulatory status

Source: Drugs@FDANDC Directory
Application number
202155
Application type
NDA · New Drug Application
Approval date
December 28, 2012
Sponsor
BRISTOL MYERS SQUIBB
Products on application
3
Submissions recorded
25
Products approved under application 202155.
Product Trade name Form Strength Ingredient Status TE Flags
202155-001 ELIQUIS TABLET APIXABAN Prescription AB RLD
202155-002 ELIQUIS TABLET APIXABAN Prescription AB RLD RS
202155-003 ELIQUIS TABLET, FOR SUSPENSION APIXABAN Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
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.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
6967208 November 21, 2026 001 Yes U-1501 January 25, 2013
6967208 November 21, 2026 001 Yes U-1200 January 25, 2013
6967208 November 21, 2026 001 Yes U-1302 January 25, 2013
6967208 November 21, 2026 001 Yes U-1729 January 25, 2013
6967208 November 21, 2026 001 Yes U-1730 January 25, 2013
6967208 November 21, 2026 001 Yes U-1301 January 25, 2013
6967208 November 21, 2026 001 Yes U-1167 January 25, 2013
6967208 November 21, 2026 001 Yes U-4178 January 25, 2013
6967208 November 21, 2026 001 Yes U-1323 January 25, 2013
6967208 November 21, 2026 001 Yes U-1502 January 25, 2013
6967208 November 21, 2026 002 Yes U-1301 January 25, 2013
6967208 November 21, 2026 002 Yes U-1200 January 25, 2013
6967208 November 21, 2026 002 Yes U-1302 January 25, 2013
6967208 November 21, 2026 002 Yes U-1323 January 25, 2013
6967208 November 21, 2026 002 Yes U-4178 January 25, 2013
6967208 November 21, 2026 003 Yes U-4179 May 16, 2025
6967208*PED May 21, 2027 001 No —
6967208*PED May 21, 2027 002 No —
6967208*PED May 21, 2027 003 No —
9326945 February 24, 2031 001 No May 26, 2016
9326945 February 24, 2031 002 No May 26, 2016
9326945 February 24, 2031 003 No May 16, 2025
9326945*PED August 24, 2031 001 No —
9326945*PED August 24, 2031 002 No —
9326945*PED August 24, 2031 003 No —
Regulatory exclusivity periods.
Code Expires Product
NPP April 17, 2028 001
NPP April 17, 2028 002
NS April 17, 2028 003
PED October 17, 2028 001
PED October 17, 2028 002
PED October 17, 2028 003

Approval history

Source: Drugs@FDA
Most recent submissions on application 202155.
Type No. Action Status Date Review
Supplement 42 Labeling Approved June 24, 2026 Standard
Supplement 40 Efficacy Approved April 17, 2025 Priority
Supplement 39 Efficacy Approved April 17, 2025 Priority
Supplement 34 Labeling Approved October 12, 2021 Standard
Supplement 32 Labeling Approved April 20, 2021 Standard
Supplement 24 Labeling Approved November 26, 2019 Standard
Supplement 21 Labeling Approved June 3, 2019 Standard
Supplement 20 Labeling Approved June 28, 2018 Standard
Supplement 18 Labeling Approved February 9, 2018 Standard
Supplement 17 Labeling Approved November 29, 2017 Standard
Supplement 12 Labeling Approved July 20, 2016 Standard
Supplement 13 Manufacturing (CMC) Approved May 3, 2016 Priority
Supplement 14 REMS Approved March 2, 2016 N/A
Supplement 11 Labeling Approved September 10, 2015 Standard
Supplement 10 Labeling Approved June 16, 2015 Standard
Supplement 8 Manufacturing (CMC) Approved May 1, 2015 Priority
Supplement 5 Manufacturing (CMC) Approved March 9, 2015 Priority
Supplement 6 Efficacy Approved August 21, 2014 Standard
Supplement 9 REMS Approved August 12, 2014 N/A
Supplement 7 Manufacturing (CMC) Approved April 30, 2014 Priority
Supplement 3 Efficacy Approved March 13, 2014 Standard
Supplement 2 Labeling Approved January 30, 2014 Standard
Supplement 4 Labeling Approved October 31, 2013 Standard
Supplement 1 Manufacturing (CMC) Approved July 16, 2013 Priority
Original application 1 Type 1 - New Molecular Entity Approved December 28, 2012 Priority

Review documents

  • 0 · Supplement · June 29, 2026
  • 0 · Supplement · June 26, 2026
  • 0 · Supplement · December 12, 2025
  • 0 · Supplement · December 12, 2025
  • 0 · Supplement · April 28, 2025
  • 0 · Supplement · April 28, 2025
  • 0 · Supplement · October 13, 2021
  • 0 · Supplement · October 13, 2021
  • 0 · Supplement · October 13, 2021
  • 0 · Supplement · April 22, 2021
  • 0 · Supplement · April 22, 2021
  • 0 · Supplement · November 27, 2019
  • 0 · Supplement · November 27, 2019
  • 0 · Supplement · June 5, 2019
  • 0 · Supplement · June 4, 2019
  • 0 · Supplement · July 6, 2018
  • 0 · Supplement · July 5, 2018
  • 0 · Supplement · February 14, 2018
  • 0 · Supplement · February 12, 2018
  • 0 · Supplement · December 1, 2017
  • 0 · Supplement · November 30, 2017
  • 0 · Supplement · July 22, 2016
  • 0 · Supplement · July 21, 2016
  • 0 · Supplement · May 3, 2016
  • 0 · Supplement · March 4, 2016
  • 0 · Supplement · September 14, 2015
  • 0 · Supplement · September 11, 2015
  • 0 · Supplement · June 19, 2015
  • 0 · Supplement · June 18, 2015
  • 0 · Supplement · September 10, 2014

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
0003-3764-74 0003-3764 E.R. Squibb & Sons, L.L.C. 1 KIT in 1 CARTON (0003-3764-74) * 32 TABLET, COATED in 1 BLISTER PACK * 42 TABLET, COATED in 1 BLISTER PACK November 30, 2017
0003-3764 0003-3764 E.R. Squibb & Sons, L.L.C. — November 29, 2017
0003-3765 0003-3765 E.R. Squibb & Sons, L.L.C. — November 29, 2017

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

Generated September 25, 2026 · 9 sections on this page.