Metronidazole

Product NDC: 50090-5688
11-digit product format: 500905688
Labeler code: 50090
Product ID: 50090-5688_5f625791-0a74-4167-9be2-69aeba4d19e8
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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-5688		D	Discontinued by firm	2026-08-17
excluded package	package	50090-5688	50090-5688-0	D	Discontinued by firm	2026-08-17
excluded package	package	50090-5688	50090-5688-1	D	Discontinued by firm	2026-08-17
excluded package	package	50090-5688	50090-5688-2	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 · 4 matching rows.

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

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	50090-5688-0
excluded package	package	50090-5688-2
excluded package	package	50090-5688-1

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55	Product name	5	20251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17	Product name	1	20250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1	Product name	5	20250515
e1aac33b-94ae-4ee9-905b-299f7263853b	Product name	3	20250124
16642716-d28a-4f90-8dcb-3921cd8c8109	Product name	4	20240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
a5070875-62bb-61e1-fd46-8f7054197a40	Product name	8	20180215
0add4de9-d152-3375-3390-1123dddc5e3d	Product name	1	20140508
33ca0fcc-1011-92dc-50a9-a383683eed1e	Product name	1	20140508
53f39d9f-cd3f-04e1-c668-d4580719d57d	Product name	1	20140508
a804000f-b74f-0b5d-d17b-aa767c286ddb	Product name	1	20140508
a91ea265-6e02-c08f-93c8-686d54180529	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5688-1	EA - Each	50090-5688	0633c614-f94b-4377-9cdf-3039edc75965	1	2022-08-04
50090-5688-2	EA - Each	50090-5688	3ad73bf2-a6a5-4a04-bb20-da0e0c752656	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5688	METRONIDAZOLE TABLET [A-S MEDICATION SOLUTIONS]	6	Legacy NDC	20231210_0d3257b0-ec6d-4f6f-80ff-4adcffcee35f.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
50090-5688-0	50090568800	15 TABLET in 1 BOTTLE (50090-5688-0)	15 tablet	2021-09-21	0000-00-00	No	No	Current
50090-5688-1	50090568801	30 TABLET in 1 BOTTLE (50090-5688-1)	30 tablet	2022-01-20	0000-00-00	No	No	Current
50090-5688-2	50090568802	42 TABLET in 1 BOTTLE (50090-5688-2)	42 tablet	2022-01-20	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	2023-12-09	Human Prescription Drug Label	6