Metronidazole

Product NDC: 55289-521
Requested package NDC: 55289-521-21
11-digit product format: 552890521
Labeler code: 55289
Product ID: 55289-521_da2f2294-6760-6ddb-e053-2a95a90a1e5b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA070033
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: METRONIDAZOLE
Active strength: 500 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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	55289-521	55289-521-21	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A070033-001	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		1984-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070033-001	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 · 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	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070033-001	METRONIDAZOLE	500MG	TABLET / ORAL	AB	1984-12-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070033-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070033-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070033-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070033-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070033-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070033-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070033-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070033-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070033-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070033-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070033-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070033-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070033-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070033-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070033-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070033-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070033-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070033-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070033-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070033-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070033-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070033-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070033-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070033-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070033-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070033-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070033-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070033-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070033-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070033-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070033-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070033-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070033-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070033-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070033-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070033-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070033-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070033-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070033-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070033-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-521-04	EA - Each	55289-521	d87a6ff6-7f36-4451-9891-eea1e7acab51	1	2012-07-24
55289-521-06	EA - Each	55289-521	1ebb981d-1645-4eb9-9419-309b74e0a6a8	1	2013-03-03
55289-521-08	EA - Each	55289-521	8d0cbfdb-ad71-465a-b832-9b652c3e9e39	1	2012-07-24
55289-521-09	EA - Each	55289-521	83d5f0df-a055-400e-8209-41dcd8efcf86	1	2013-03-03
55289-521-10	EA - Each	55289-521	2fecdb4e-53cc-46b1-81e7-cacaefbc72c0	1	2012-07-24
55289-521-14	EA - Each	55289-521	67ccc5ee-b006-413f-9d33-b2d25d4832e2	1	2012-07-24
55289-521-21	EA - Each	55289-521	4f3a53e8-8314-4418-9c38-2831d318e528	1	2012-07-24
55289-521-25	EA - Each	55289-521	a498a00b-2dac-4744-aa88-fece42b12d42	1	2017-08-11
55289-521-28	EA - Each	55289-521	81d9408a-d768-46d9-b1dd-d8b4ddb036b1	1	2012-07-24
55289-521-30	EA - Each	55289-521	4692e4a4-4736-4294-b41a-933f712e7987	1	2012-07-24
55289-521-40	EA - Each	55289-521	62efb901-9606-48a7-93e6-93897ffda010	1	2012-07-24
55289-521-79	EA - Each	55289-521	e0c08388-40e3-415b-bbbe-9cc469fa0bd5	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE (METRONIDAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE (METRONIDAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE (METRONIDAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE (METRONIDAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE (METRONIDAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METRONIDAZOLE (METRONIDAZOLE) TABLET [PD-RX PHARMACEUTICALS, INC.]	6

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	53918705-d2fe-4c6b-9501-a619a8ad3991	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	1a28dce0-07af-401a-a6ac-1c2ee559c668	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033
Metronidazole	METRONIDAZOLE	Redpharm Drug, inc.	f426cddc-8b70-c0a7-e053-2995a90a74e0	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	e1e7e127-e99e-80e9-1606-71261658b0c1	2024-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033
Metronidazole	METRONIDAZOLE	Proficient Rx LP	e313c7d9-fb7b-4d0f-bccf-cc72ac5ef205	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033
Metronidazole	METRONIDAZOLE	Teva Pharmaceuticals USA, Inc.	291a45f6-ed27-4dcc-8364-358d08623797	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070033 application number: ANDA070033

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
140QMO216E	METRONIDAZOLE	443-48-1	METRONIDAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-521-21	55289052121	21 TABLET in 1 BOTTLE, PLASTIC (55289-521-21)	21 tablet	2012-07-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2022-03-14	HUMAN PRESCRIPTION DRUG LABEL	13