Sodium Phenylbutyrate

Product NDC: 42794-086
11-digit product format: 427940086
Labeler code: 42794
Product ID: 42794-086_d70f7f7c-f27a-db94-e053-2995a90a6937
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Phenylbutyrate
Dosage form: POWDER
Route: ORAL
Labeler: Sigmapharm Laboratories, LLC
Application: ANDA202819
Marketing category: ANDA
Marketing start: 2013-04-08
Substance: SODIUM PHENYLBUTYRATE
Active strength: .94 g/g
Pharmacologic classes: Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42794-086		D	Discontinued by firm		2026-08-03
excluded package	package	42794-086	42794-086-14	D	Discontinued by firm		2026-08-03

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202819-001	SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL			2013-03-22

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202819-001	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER / ORAL	AB	2013-03-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202819-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202819-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202819-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202819-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202819-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202819-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202819-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202819-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202819-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202819-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202819-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202819-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202819-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202819-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202819-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202819-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202819-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202819-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202819-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202819-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202819-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202819-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202819-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202819-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202819-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202819-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202819-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202819-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202819-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202819-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202819-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202819-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202819-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202819-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202819-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202819-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202819-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202819-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202819-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202819-001	AB	1	`cb3db0bc1861…`

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
42794-086-14	Sodium Phenylbutyrate	250 g in 1 BOTTLE	POWDER	250		5
42794-086-14	Sodium Phenylbutyrate	1 in 1 CARTON	POWDER	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42794-086-14	GM - Gram	42794-086	9f48ab0c-c035-4855-8e75-5aedc085d92a	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM PHENYLBUTYRATE	ACTIVE INGREDIENT	NT6K61736T	SODIUM PHENYLBUTYRATE POWDER [SIGMAPHARM LABORATORIES, LLC]	1
PHENYLBUTYRIC ACID	ACTIVE MOIETY	7WY7YBI87E	SODIUM PHENYLBUTYRATE POWDER [SIGMAPHARM LABORATORIES, LLC]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	SODIUM PHENYLBUTYRATE POWDER [SIGMAPHARM LABORATORIES, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SODIUM PHENYLBUTYRATE POWDER [SIGMAPHARM LABORATORIES, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42794-086	SODIUM PHENYLBUTYRATE POWDER [SIGMAPHARM LABORATORIES, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20220203_e914d451-6122-43f9-af8d-c80ed1cb215d.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
984105	sodium phenylbutyrate 0.94 GM/GM Oral Powder	PSN	e914d451-6122-43f9-af8d-c80ed1cb215d	5
984105	sodium phenylbutyrate 0.94 MG/MG Oral Powder	SCD	e914d451-6122-43f9-af8d-c80ed1cb215d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42794-086-14	42794008614	1 BOTTLE in 1 CARTON (42794-086-14) / 250 g in 1 BOTTLE	1 bottle	2013-04-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Phenylbutyrate Powder (SO-dee-um fen-ill-BYOU-tih-rate) Rx Only	Sigmapharm Laboratories, LLC	2022-02-02	HUMAN PRESCRIPTION DRUG LABEL	5