OLPRUVA — Kit

Overview

Brand name

OLPRUVA

Generic name

sodium phenylbutyrate

Dosage form

Kit

Route

Oral

Marketing category

NDA · NDA

Labeler

Acer Therapeutics Inc.

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

0

NDC product codes

6

Packages

6

Data completeness

60% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory

Dosage form

Kit

Route of administration

Oral

Presentations

12

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

214860

Application type

NDA · New Drug Application

Approval date

December 22, 2022

Sponsor

ACER

Products on application

8

Submissions recorded

2

Products approved under application 214860.
Product	Trade name	Form	Ingredient	Status	TE	Flags
214860-001	OLPRUVA	FOR SUSPENSION	SODIUM PHENYLBUTYRATE	Prescription	—	RLD
214860-002	OLPRUVA	FOR SUSPENSION	SODIUM PHENYLBUTYRATE	Prescription	—	RLD
214860-003	OLPRUVA	FOR SUSPENSION	SODIUM PHENYLBUTYRATE	Prescription	—	RLD
214860-004	OLPRUVA	FOR SUSPENSION	SODIUM PHENYLBUTYRATE	Prescription	—	RLD RS
214860-005	OLPRUVA	FOR SUSPENSION	SODIUM PHENYLBUTYRATE	Prescription	—	RLD
214860-006	OLPRUVA	FOR SUSPENSION	SODIUM PHENYLBUTYRATE	Prescription	—	RLD
214860-007	OLPRUVA	FOR SUSPENSION	SODIUM PHENYLBUTYRATE	Prescription	—	RLD
214860-008	OLPRUVA	FOR SUSPENSION	SODIUM PHENYLBUTYRATE	Prescription	—	RLD

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

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
11202767	October 17, 2036	001	No	U-3502	January 12, 2023
11433041	October 17, 2036	001	No		January 12, 2023
11154521	October 17, 2036	001	No		January 12, 2023
11202767	October 17, 2036	002	No	U-3502	January 12, 2023
11433041	October 17, 2036	002	No		January 12, 2023
11154521	October 17, 2036	002	No		January 12, 2023
11202767	October 17, 2036	003	No	U-3502	January 12, 2023
11154521	October 17, 2036	003	No		January 12, 2023
11433041	October 17, 2036	003	No		January 12, 2023
11202767	October 17, 2036	004	No	U-3502	January 12, 2023
11154521	October 17, 2036	004	No		January 12, 2023
11433041	October 17, 2036	004	No		January 12, 2023
11202767	October 17, 2036	005	No	U-3502	January 12, 2023
11154521	October 17, 2036	005	No		January 12, 2023
11433041	October 17, 2036	005	No		January 12, 2023
11202767	October 17, 2036	006	No	U-3502	January 12, 2023
11433041	October 17, 2036	006	No		January 12, 2023
11154521	October 17, 2036	006	No		January 12, 2023
11202767	October 17, 2036	007	No	U-3502	November 7, 2025
11433041	October 17, 2036	007	No		November 7, 2025
11154521	October 17, 2036	007	No		November 7, 2025
11202767	October 17, 2036	008	No	U-3502	November 7, 2025
11433041	October 17, 2036	008	No		November 7, 2025
11154521	October 17, 2036	008	No		November 7, 2025

Approval history

Source: Drugs@FDA

Most recent submissions on application 214860.
Type	No.	Action	Status	Date	Review
Supplement	7	Efficacy	Approved	October 10, 2025	Standard
Original application	1	Type 5 - New Formulation or New Manufacturer	Approved	December 22, 2022	Standard

Review documents

0 · Supplement · October 15, 2025
0 · Supplement · October 14, 2025
0 · Original application · September 29, 2023
0 · Original application · December 27, 2022
0 · Original application · December 23, 2022

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
72542-200-09	72542-200	Acer Therapeutics Inc.	90 BOX in 1 CARTON (72542-200-09) / 1 KIT in 1 BOX (72542-200-02) * 1 FOR SUSPENSION in 1 PACKET (72542-002-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01)	December 22, 2022
72542-300-09	72542-300	Acer Therapeutics Inc.	90 BOX in 1 CARTON (72542-300-09) / 1 KIT in 1 BOX (72542-300-02) * 1 FOR SUSPENSION in 1 PACKET (72542-003-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01)	December 22, 2022
72542-400-18	72542-400	Acer Therapeutics Inc.	90 BOX in 1 CARTON (72542-400-18) / 1 KIT in 1 BOX (72542-400-02) * 1 FOR SUSPENSION in 1 PACKET (72542-002-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01)	December 22, 2022
72542-500-18	72542-500	Acer Therapeutics Inc.	90 BOX in 1 CARTON (72542-500-18) / 1 KIT in 1 BOX (72542-500-02) * 1 FOR SUSPENSION in 1 PACKET (72542-003-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01) * 1 FOR SUSPENSION in 1 PACKET (72542-002-01)	December 22, 2022
72542-600-18	72542-600	Acer Therapeutics Inc.	90 BOX in 1 CARTON (72542-600-18) / 1 KIT in 1 BOX (72542-600-02) * 1 FOR SUSPENSION in 1 PACKET (72542-003-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01)	December 22, 2022
72542-667-18	72542-667	Acer Therapeutics Inc.	90 BOX in 1 CARTON (72542-667-18) / 1 KIT in 1 BOX (72542-667-02) * 1 FOR SUSPENSION in 1 PACKET (72542-367-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01) * 1 FOR SUSPENSION in 1 PACKET (72542-003-01)	December 22, 2022
72542-200	72542-200	Acer Therapeutics Inc.	—	December 22, 2022
72542-300	72542-300	Acer Therapeutics Inc.	—	December 22, 2022
72542-400	72542-400	Acer Therapeutics Inc.	—	December 22, 2022
72542-500	72542-500	Acer Therapeutics Inc.	—	December 22, 2022
72542-600	72542-600	Acer Therapeutics Inc.	—	December 22, 2022
72542-667	72542-667	Acer Therapeutics Inc.	—	December 22, 2022

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 · 8 sections on this page.