Metronidazole

Product NDC: 50090-5687
Requested package NDC: 50090-5687-3
11-digit product format: 500905687
Labeler code: 50090
Product ID: 50090-5687_66b1da4c-2833-49ef-9f42-151dd8d99fcd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA203974
Marketing category: ANDA
Marketing start: 2015-05-29
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: 2022-12-31
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	50090-5687	50090-5687-3	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5687	50090-5687-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5687	50090-5687-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203974-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29
A203974-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203974-001	AB
A203974-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2015-05-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203974-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203974-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203974-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203974-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203974-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203974-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203974-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203974-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203974-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203974-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203974-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203974-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203974-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203974-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203974-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203974-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203974-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203974-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203974-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203974-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203974-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203974-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203974-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203974-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203974-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203974-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203974-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203974-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203974-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203974-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203974-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203974-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203974-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203974-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203974-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203974-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203974-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203974-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203974-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203974-002	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-5687-0	2023-02-06	Metronidazole Tablets USP Rx only
50090-5687-3	2023-02-06	Metronidazole Tablets USP Rx only
50090-5687-4	2023-02-06	Metronidazole Tablets USP Rx only
50090-5687-6	2023-02-06	Metronidazole Tablets USP Rx only
50090-5687-9	2023-02-06	Metronidazole Tablets USP Rx only
50090-5687-0	2023-01-30	Metronidazole Tablets USP Rx only
50090-5687-3	2023-01-30	Metronidazole Tablets USP Rx only
50090-5687-4	2023-01-30	Metronidazole Tablets USP Rx only
50090-5687-6	2023-01-30	Metronidazole Tablets USP Rx only
50090-5687-9	2023-01-30	Metronidazole Tablets USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5687-0	EA - Each	50090-5687	c35d08bc-2880-465d-b417-ab3d74029c36	1	2022-10-06
50090-5687-3	EA - Each	50090-5687	3cf6b019-729b-4777-b88d-1662185fc927	1	2022-10-06
50090-5687-4	EA - Each	50090-5687	6e128a19-9fc5-4fce-8780-3152daaa74ec	1	2022-10-06
50090-5687-6	EA - Each	50090-5687	55de62c3-4a9d-4e66-835c-e2365ec64d28	1	2022-10-06
50090-5687-9	EA - Each	50090-5687	5eec18c3-fdcf-4f3a-be74-1a8f332c89b7	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5687	METRONIDAZOLE TABLET [A-S MEDICATION SOLUTIONS]	3	Legacy NDC	20230208_6c0e6c95-9107-4ad2-bd82-041c208d4d44.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	dc28753c-95ec-4b41-ad77-c4a66698d9db	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	c225a455-ec25-2213-e053-2995a90a3389	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	2fa14353-45df-429c-8759-7d66a65f08f0	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	92e58420-1d99-4a92-b1f3-a7f791ca7187	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974
Metronidazole	METRONIDAZOLE	Rising Pharma Holdings, Inc.	93e4f174-4fe0-4cfd-a0cf-d0963e082107	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974
Metronidazole	METRONIDAZOLE	Aurobindo Pharma Limited	f68397ee-67db-472e-8607-4300064e37df	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	bff2f5bd-75a4-4252-a643-c21741ae8a96	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974

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
50090-5687-3	50090568703	14 TABLET in 1 BOTTLE (50090-5687-3)	14 tablet	2021-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets USP Rx only	A-S Medication Solutions	2023-02-06	Human Prescription Drug Label	3