Pyrazinamide

Product NDC: 70954-484
11-digit product format: 709540484
Labeler code: 70954
Product ID: 70954-484_e043f21d-4a30-4d23-bc03-12207af7d6d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pyrazinamide
Dosage form: TABLET
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA080157
Marketing category: ANDA
Marketing start: 2021-05-11
Substance: PYRAZINAMIDE
Active strength: 500 mg/1
Pharmacologic classes: Antimycobacterial [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70954-484	70954-484-40	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A080157-001	PYRAZINAMIDE	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A080157-001	AB

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL		Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL		Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL		Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL		Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A080157-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080157-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080157-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080157-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080157-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080157-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080157-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080157-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080157-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080157-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080157-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080157-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080157-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080157-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080157-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080157-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080157-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080157-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080157-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080157-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080157-001	AB	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A080157-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080157-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080157-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080157-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080157-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080157-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080157-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080157-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080157-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080157-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080157-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080157-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080157-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080157-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080157-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080157-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080157-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PYRAZINAMIDE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2KNI5N06TI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198181	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
262d8829-728c-48db-b89b-88d13b87e684	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
74627275-f344-a42f-8f8b-d6190f614e0e	Product name	2	20210211
7cf7f62d-3767-728f-c117-96e96c1ed8bf	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70954-484-10	Pyrazinamide	60 in 1 BOTTLE	TABLET	60	2
70954-484-20	Pyrazinamide	90 in 1 BOTTLE	TABLET	90	2
70954-484-30	Pyrazinamide	100 in 1 BOTTLE	TABLET	100	2
70954-484-40	Pyrazinamide	500 in 1 BOTTLE	TABLET	500	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70954-484-10	EA - Each	70954-484	5aca53e7-6b0c-4841-adfc-a9f1b5a37e60	1	2021-08-05
70954-484-20	EA - Each	70954-484	cc040fd8-bd5e-47ac-bff1-a396a786fc67	1	2021-08-05
70954-484-30	EA - Each	70954-484	a829b817-b002-46e6-bfdf-039e5df91e4e	1	2021-08-05
70954-484-40	EA - Each	70954-484	72741e30-9761-48f6-89ae-dfe90b1a3f9f	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70954-484	PYRAZINAMIDE TABLET [NOVITIUM PHARMA LLC]	1	Current NDC, Legacy NDC, 4 package rows	20210514_262d8829-728c-48db-b89b-88d13b87e684.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pyrazinamide	PYRAZINAMIDE	ANI Pharmaceuticals, Inc.	262d8829-728c-48db-b89b-88d13b87e684	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080157 application number: ANDA080157 ndc (product): 70954-484
PYRAZINAMIDE	PYRAZINAMIDE TABLET	MARLEX PHARMACEUTICALS, INC	db250a85-2e20-87e9-e053-2a95a90a72b6	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080157 application number: ANDA080157
Pyrazinamide	PYRAZINAMIDE	American Health Packaging	e2dbbdf9-ddfd-4d6d-ad42-6e658969f11e	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080157 application number: ANDA080157

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2KNI5N06TI	PYRAZINAMIDE	98-96-4	PYRAZINAMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198181	pyrazinamide 500 MG Oral Tablet	PSN	db250a85-2e20-87e9-e053-2a95a90a72b6	5
198181	pyrazinamide 500 MG Oral Tablet	SCD	db250a85-2e20-87e9-e053-2a95a90a72b6	5
198181	PZA 500 MG Oral Tablet	SY	db250a85-2e20-87e9-e053-2a95a90a72b6	5
198181	pyrazinamide 500 MG Oral Tablet	PSN	262d8829-728c-48db-b89b-88d13b87e684	2
198181	pyrazinamide 500 MG Oral Tablet	PSN	e2dbbdf9-ddfd-4d6d-ad42-6e658969f11e	2
198181	pyrazinamide 500 MG Oral Tablet	SCD	262d8829-728c-48db-b89b-88d13b87e684	2
198181	pyrazinamide 500 MG Oral Tablet	SCD	e2dbbdf9-ddfd-4d6d-ad42-6e658969f11e	2
198181	PZA 500 MG Oral Tablet	SY	262d8829-728c-48db-b89b-88d13b87e684	2
198181	PZA 500 MG Oral Tablet	SY	e2dbbdf9-ddfd-4d6d-ad42-6e658969f11e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70954-484-10	70954048410	60 TABLET in 1 BOTTLE (70954-484-10)	60 tablet	2021-05-11	0000-00-00	No	No	Current
70954-484-20	70954048420	90 TABLET in 1 BOTTLE (70954-484-20)	90 tablet	2021-05-11	0000-00-00	No	No	Current
70954-484-30	70954048430	100 TABLET in 1 BOTTLE (70954-484-30)	100 tablet	2021-05-11	0000-00-00	No	No	Current
70954-484-40	70954048440	500 TABLET in 1 BOTTLE (70954-484-40)	500 tablet	2021-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pyrazinamide Tablets, USP 500 mg Rx Only	ANI Pharmaceuticals, Inc. \| Novitium Pharma LLC	2026-03-02	Human Prescription Drug Label	2
pyrazinamide tablet	MARLEX PHARMACEUTICALS, INC	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	5
Pyrazinamide Tablets, USP Rx Only 8478901/0923F	American Health Packaging	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL	2
Pyrazinamide Tablets, USP 500 mg Rx Only	RPK Pharmaceuticals, Inc.	2024-12-19	Human Prescription Drug Label	3
Pyrazinamide Tablets, USP 500 mg Rx Only	REMEDYREPACK INC.	2024-03-27	HUMAN PRESCRIPTION DRUG LABEL	2
Pyrazinamide Tablets, USP 500 mg Rx Only	A-S Medication Solutions	2023-11-22	Human Prescription Drug Label	3