Pyrazinamide

Product NDC: 33342-447
11-digit product format: 333420447
Labeler code: 33342
Product ID: 33342-447_3695f057-de86-4c9a-9d43-ff0a6acdffe7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pyrazinamide
Dosage form: TABLET
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA212541
Marketing category: ANDA
Marketing start: 2020-07-27
Substance: PYRAZINAMIDE
Active strength: 500 mg/1
Pharmacologic classes: Antimycobacterial [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A212541-001	PYRAZINAMIDE	PYRAZINAMIDE	500MG	TABLET / ORAL	AB		2020-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212541-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212541-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	2020-07-27	`a50c72e98297…`

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	A212541-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212541-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212541-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212541-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212541-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212541-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212541-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212541-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212541-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212541-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212541-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212541-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212541-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212541-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212541-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212541-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212541-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212541-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212541-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212541-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212541-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212541-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212541-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212541-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212541-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212541-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212541-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212541-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212541-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212541-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212541-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212541-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212541-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212541-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212541-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212541-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212541-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212541-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pyrazinamide
Listing expiration: 2026-12-31

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
a8b7ba02-8509-475b-8a3b-39d205af3f1e	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
33342-447-03	Pyrazinamide	10 in 1 BOTTLE	TABLET	10	2
33342-447-07	Pyrazinamide	30 in 1 BOTTLE	TABLET	30	2
33342-447-09	Pyrazinamide	60 in 1 BOTTLE	TABLET	60	2
33342-447-10	Pyrazinamide	90 in 1 BOTTLE	TABLET	90	2
33342-447-11	Pyrazinamide	100 in 1 BOTTLE	TABLET	100	2
33342-447-12	Pyrazinamide	10 in 1 BLISTER PACK	TABLET	10	2
33342-447-15	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
33342-447-11	EA - Each	33342-447	f56703f9-2637-4b75-b9a4-0f8bd2d2f43c	1	2021-12-08
33342-447-15	EA - Each	33342-447	87e28ca8-0cfe-470c-90d9-e35127fb2e17	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-447	PYRAZINAMIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]	2	Current NDC, Legacy NDC, 7 package rows	20230101_a8b7ba02-8509-475b-8a3b-39d205af3f1e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pyrazinamide	PYRAZINAMIDE	Macleods Pharmaceuticals Limited	a8b7ba02-8509-475b-8a3b-39d205af3f1e	2022-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212541 application number: ANDA212541 ndc (product): 33342-447

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	a8b7ba02-8509-475b-8a3b-39d205af3f1e	2
198181	pyrazinamide 500 MG Oral Tablet	SCD	a8b7ba02-8509-475b-8a3b-39d205af3f1e	2
198181	PZA 500 MG Oral Tablet	SY	a8b7ba02-8509-475b-8a3b-39d205af3f1e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
33342-447-03	33342044703	10 TABLET in 1 BOTTLE (33342-447-03)	10 tablet	2020-07-27	0000-00-00	No	No	Current
33342-447-07	33342044707	30 TABLET in 1 BOTTLE (33342-447-07)	30 tablet	2020-07-27	0000-00-00	No	No	Current
33342-447-09	33342044709	60 TABLET in 1 BOTTLE (33342-447-09)	60 tablet	2020-07-27	0000-00-00	No	No	Current
33342-447-10	33342044710	90 TABLET in 1 BOTTLE (33342-447-10)	90 tablet	2020-07-27	0000-00-00	No	No	Current
33342-447-11	33342044711	100 TABLET in 1 BOTTLE (33342-447-11)	100 tablet	2020-07-27	0000-00-00	No	No	Current
33342-447-12	33342044712	10 TABLET in 1 BLISTER PACK (33342-447-12)	10 tablet	2020-07-27	0000-00-00	No	No	Current
33342-447-15	33342044715	500 TABLET in 1 BOTTLE (33342-447-15)	500 tablet	2020-07-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PYRAZINAMIDE Tablets, USP 500 mg	Macleods Pharmaceuticals Limited	2022-12-06	Human Prescription Drug Label	2