OLPRUVA

Product NDC: 72542-667
11-digit product format: 725420667
Labeler code: 72542
Product ID: 72542-667_7720f74d-f161-4aaa-a421-7bf48e6c962c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sodium phenylbutyrate
Dosage form: KIT
Route: ORAL
Labeler: Acer Therapeutics Inc.
Application: NDA214860
Marketing category: NDA
Marketing start: 2022-12-22
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214860-001	OLPRUVA	SODIUM PHENYLBUTYRATE	2GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22
N214860-002	OLPRUVA	SODIUM PHENYLBUTYRATE	3GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22
N214860-003	OLPRUVA	SODIUM PHENYLBUTYRATE	4GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22
N214860-004	OLPRUVA	SODIUM PHENYLBUTYRATE	5GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2022-12-22
N214860-005	OLPRUVA	SODIUM PHENYLBUTYRATE	6GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22
N214860-006	OLPRUVA	SODIUM PHENYLBUTYRATE	6.67GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22
N214860-007	OLPRUVA	SODIUM PHENYLBUTYRATE	0.5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2025-10-10
N214860-008	OLPRUVA	SODIUM PHENYLBUTYRATE	1GM/PACKET	FOR SUSPENSION / ORAL	RLD	2025-10-10

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214860-001	11154521	2036-10-17		Drug product	2023-01-12
N214860-001	11202767	2036-10-17	U-3502		2023-01-12
N214860-001	11433041	2036-10-17		Drug product	2023-01-12
N214860-002	11154521	2036-10-17		Drug product	2023-01-12
N214860-002	11202767	2036-10-17	U-3502		2023-01-12
N214860-002	11433041	2036-10-17		Drug product	2023-01-12
N214860-003	11154521	2036-10-17		Drug product	2023-01-12
N214860-003	11202767	2036-10-17	U-3502		2023-01-12
N214860-003	11433041	2036-10-17		Drug product	2023-01-12
N214860-004	11154521	2036-10-17		Drug product	2023-01-12
N214860-004	11202767	2036-10-17	U-3502		2023-01-12
N214860-004	11433041	2036-10-17		Drug product	2023-01-12
N214860-005	11154521	2036-10-17		Drug product	2023-01-12
N214860-005	11202767	2036-10-17	U-3502		2023-01-12
N214860-005	11433041	2036-10-17		Drug product	2023-01-12
N214860-006	11154521	2036-10-17		Drug product	2023-01-12
N214860-006	11202767	2036-10-17	U-3502		2023-01-12
N214860-006	11433041	2036-10-17		Drug product	2023-01-12
N214860-007	11154521	2036-10-17		Drug product	2025-11-07
N214860-007	11202767	2036-10-17	U-3502		2025-11-07
N214860-007	11433041	2036-10-17		Drug product	2025-11-07
N214860-008	11154521	2036-10-17		Drug product	2025-11-07
N214860-008	11202767	2036-10-17	U-3502		2025-11-07
N214860-008	11433041	2036-10-17		Drug product	2025-11-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 150 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214860-001	OLPRUVA	2GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-002	OLPRUVA	3GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-003	OLPRUVA	4GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-004	OLPRUVA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2022-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-005	OLPRUVA	6GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-006	OLPRUVA	6.67GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-007	OLPRUVA	0.5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2025-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-008	OLPRUVA	1GM/PACKET	FOR SUSPENSION / ORAL	RLD	2025-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-001	OLPRUVA	2GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-002	OLPRUVA	3GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-003	OLPRUVA	4GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-004	OLPRUVA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2022-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-005	OLPRUVA	6GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-006	OLPRUVA	6.67GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-007	OLPRUVA	0.5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2025-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-008	OLPRUVA	1GM/PACKET	FOR SUSPENSION / ORAL	RLD	2025-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214860-001	OLPRUVA	2GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214860-002	OLPRUVA	3GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214860-003	OLPRUVA	4GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214860-004	OLPRUVA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2022-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214860-005	OLPRUVA	6GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214860-006	OLPRUVA	6.67GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214860-001	OLPRUVA	2GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214860-002	OLPRUVA	3GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214860-003	OLPRUVA	4GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214860-004	OLPRUVA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2022-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214860-005	OLPRUVA	6GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214860-006	OLPRUVA	6.67GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214860-001	OLPRUVA	2GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214860-002	OLPRUVA	3GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214860-003	OLPRUVA	4GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214860-004	OLPRUVA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2022-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214860-005	OLPRUVA	6GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214860-006	OLPRUVA	6.67GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214860-001	OLPRUVA	2GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214860-002	OLPRUVA	3GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214860-003	OLPRUVA	4GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214860-004	OLPRUVA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2022-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214860-005	OLPRUVA	6GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214860-006	OLPRUVA	6.67GM/PACKET	FOR SUSPENSION / ORAL	RLD	2022-12-22	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 432 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214860-001	11154521	2036-10-17		Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-001	11202767	2036-10-17	U-3502		2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-001	11433041	2036-10-17		Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-002	11154521	2036-10-17		Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-002	11202767	2036-10-17	U-3502		2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-002	11433041	2036-10-17		Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-003	11154521	2036-10-17		Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-003	11202767	2036-10-17	U-3502		2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-003	11433041	2036-10-17		Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-004	11154521	2036-10-17		Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-004	11202767	2036-10-17	U-3502		2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-004	11433041	2036-10-17		Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-005	11154521	2036-10-17		Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-005	11202767	2036-10-17	U-3502		2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-005	11433041	2036-10-17		Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-006	11154521	2036-10-17		Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-006	11202767	2036-10-17	U-3502		2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-006	11433041	2036-10-17		Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-007	11154521	2036-10-17		Drug product	2025-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-007	11202767	2036-10-17	U-3502		2025-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-007	11433041	2036-10-17		Drug product	2025-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-008	11154521	2036-10-17		Drug product	2025-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-008	11202767	2036-10-17	U-3502		2025-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214860-008	11433041	2036-10-17		Drug product	2025-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-001	11154521	2036-10-17		Drug product	2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-001	11202767	2036-10-17	U-3502		2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-001	11433041	2036-10-17		Drug product	2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-002	11154521	2036-10-17		Drug product	2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-002	11202767	2036-10-17	U-3502		2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-002	11433041	2036-10-17		Drug product	2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-003	11154521	2036-10-17		Drug product	2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-003	11202767	2036-10-17	U-3502		2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-003	11433041	2036-10-17		Drug product	2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-004	11154521	2036-10-17		Drug product	2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-004	11202767	2036-10-17	U-3502		2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-004	11433041	2036-10-17		Drug product	2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-005	11154521	2036-10-17		Drug product	2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-005	11202767	2036-10-17	U-3502		2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-005	11433041	2036-10-17		Drug product	2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214860-006	11154521	2036-10-17		Drug product	2023-01-12	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: OLPRUVA
Listing expiration: 2027-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0cc537b1-c2e1-c627-bac5-cebf6929cf73	Product name	3	20240109
5b2d409d-7740-4999-9561-96950a3ff604	Product name	1	20230919
33ad3946-5a41-4c5a-ac56-c03c9275532f	Product name	1	20230313
80e18c01-dd53-4091-b66d-ad9549805dab	Product name	1	20221116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72542-003-01	OLPRUVA	1 in 1 PACKET	FOR SUSPENSION	1	3 g	4
72542-367-01	OLPRUVA	1 in 1 PACKET	FOR SUSPENSION	1	3.67 g	4
72542-667-02	OLPRUVA	1 in 1 BOX	KIT	1		4
72542-667-18	OLPRUVA	90 in 1 CARTON	KIT	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72542-667-02	EA - Each	72542-667	8dc1af2b-2b05-47a8-9f8a-e0b2d4d70f22	1	2023-07-06
72542-667-18	EA - Each	72542-667	cdac2ddb-2fa3-4e16-9ef3-0127d1678b96	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72542-667	OLPRUVA (SODIUM PHENYLBUTYRATE) KIT [ACER THERAPEUTICS INC.]	4	Current NDC, Legacy NDC, 4 package rows	20241220_89abc31c-43e8-4809-9eb7-172cb31a86f1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NT6K61736T	SODIUM PHENYLBUTYRATE	1716-12-7	sodium phenylbutyrate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2626387	{1 (sodium phenylbutyrate 2000 MG Granules for Oral Suspension [Olpruva]) } Pack [Olpruva 2 GM Pack]	BPCK	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626393	{1 (sodium phenylbutyrate 2000 MG Granules for Oral Suspension [Olpruva]) / 1 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension [Olpruva]) } Pack [Olpruva 5 GM Pack]	BPCK	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626389	{1 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension [Olpruva]) } Pack [Olpruva 3 GM Pack]	BPCK	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626401	{1 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension [Olpruva]) / 1 (sodium phenylbutyrate 3670 MG Granules for Oral Suspension [Olpruva]) } Pack [Olpruva 6.67 GM Pack]	BPCK	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626391	{2 (sodium phenylbutyrate 2000 MG Granules for Oral Suspension [Olpruva]) } Pack [Olpruva 4 GM Pack]	BPCK	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626395	{2 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension [Olpruva]) } Pack [Olpruva 6 GM Pack]	BPCK	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626386	{1 (sodium phenylbutyrate 2000 MG Granules for Oral Suspension) } Pack	GPCK	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626392	{1 (sodium phenylbutyrate 2000 MG Granules for Oral Suspension) / 1 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension) } Pack	GPCK	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626388	{1 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension) } Pack	GPCK	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626400	{1 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension) / 1 (sodium phenylbutyrate 3670 MG Granules for Oral Suspension) } Pack	GPCK	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626390	{2 (sodium phenylbutyrate 2000 MG Granules for Oral Suspension) } Pack	GPCK	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626394	{2 (sodium phenylbutyrate 3000 MG Granules for Oral Suspension) } Pack	GPCK	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626375	OLPRUVA 2 GM Granules for Oral Suspension	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626387	OLPRUVA 2 GM Pack	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626378	OLPRUVA 3 GM Granules for Oral Suspension	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626389	OLPRUVA 3 GM Pack	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626382	OLPRUVA 3.67 GM Granules for Oral Suspension	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626391	OLPRUVA 4 GM Pack	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626393	OLPRUVA 5 GM Pack	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626395	OLPRUVA 6 GM Pack	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626401	OLPRUVA 6.67 GM Pack	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626369	sodium phenylbutyrate 2 GM Granules for Oral Suspension	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626386	sodium phenylbutyrate 2 GM Pack	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626376	sodium phenylbutyrate 3 GM Granules for Oral Suspension	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626388	sodium phenylbutyrate 3 GM Pack	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626380	sodium phenylbutyrate 3.67 GM Granules for Oral Suspension	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626390	sodium phenylbutyrate 4 GM Pack	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626392	sodium phenylbutyrate 5 GM Pack	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626394	sodium phenylbutyrate 6 GM Pack	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626400	sodium phenylbutyrate 6.67 GM Pack	PSN	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626375	sodium phenylbutyrate 2000 MG Granules for Oral Suspension [Olpruva]	SBD	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626378	sodium phenylbutyrate 3000 MG Granules for Oral Suspension [Olpruva]	SBD	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626382	sodium phenylbutyrate 3670 MG Granules for Oral Suspension [Olpruva]	SBD	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626369	sodium phenylbutyrate 2000 MG Granules for Oral Suspension	SCD	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626376	sodium phenylbutyrate 3000 MG Granules for Oral Suspension	SCD	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626380	sodium phenylbutyrate 3670 MG Granules for Oral Suspension	SCD	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626375	Olpruva 2 GM Granules for Oral Suspension	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626387	Olpruva 2 GM Pack	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626378	Olpruva 3 GM Granules for Oral Suspension	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626389	Olpruva 3 GM Pack	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626382	Olpruva 3.67 GM Granules for Oral Suspension	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626391	Olpruva 4 GM Pack	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626393	Olpruva 5 GM Pack	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626395	Olpruva 6 GM Pack	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626401	Olpruva 6.67 GM Pack	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626369	sodium phenylbutyrate 2 GM Granules for Oral Suspension	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626386	sodium phenylbutyrate 2 GM Pack	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626376	sodium phenylbutyrate 3 GM Granules for Oral Suspension	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626388	sodium phenylbutyrate 3 GM Pack	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626380	sodium phenylbutyrate 3.67 GM Granules for Oral Suspension	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626390	sodium phenylbutyrate 4 GM Pack	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626392	sodium phenylbutyrate 5 GM Pack	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626394	sodium phenylbutyrate 6 GM Pack	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4
2626400	sodium phenylbutyrate 6.67 GM Pack	SY	89abc31c-43e8-4809-9eb7-172cb31a86f1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72542-003-01	72542000301	1 in 1 PACKET						Historical
72542-367-01	72542036701	1 in 1 PACKET						Historical
72542-667-02	72542066702	1 in 1 BOX						Historical
72542-667-18	72542066718	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)	90 box	2022-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OLPRUVA	Acer Therapeutics Inc. \| CH Chemie Uetikon GmbH \| EMSL Analytical, Inc. DBA MPL Laboratories \| Glatt Air Techniques Inc. \| Sharp Clinical Services LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	4