Metronidazole

Product NDC: 50090-0202
Requested package NDC: 50090-0202-2
11-digit product format: 500900202
Labeler code: 50090
Product ID: 50090-0202_b0612403-c433-4c3a-affb-7e631ce88100
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA070027
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: METRONIDAZOLE
Active strength: 250 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	50090-0202	50090-0202-2	I	Inactivated by FDA		2026-08-07

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A070027-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		1984-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070027-001	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	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070027-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	1984-11-06	`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	A070027-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070027-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070027-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070027-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070027-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070027-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070027-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070027-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070027-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070027-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070027-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070027-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070027-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070027-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070027-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070027-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070027-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070027-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070027-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070027-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070027-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070027-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070027-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070027-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070027-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070027-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070027-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070027-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070027-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070027-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070027-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070027-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070027-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070027-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070027-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070027-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070027-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070027-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070027-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070027-001	AB	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0202-0	2023-01-30	C162847	48780-1	f386c649-a6ea-0266-e053-dadaa90a7c1a	Metronidazole Tablets USP
50090-0202-1	2023-01-30	C162847	48780-1	f386c649-a6ea-0266-e053-dadaa90a7c1a	Metronidazole Tablets USP
50090-0202-2	2023-01-30	C162847	48780-1	f386c649-a6ea-0266-e053-dadaa90a7c1a	Metronidazole Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-0202-0	Metronidazole	21 in 1 BOTTLE	TABLET	21	26
50090-0202-1	Metronidazole	28 in 1 BOTTLE	TABLET	28	26
50090-0202-2	Metronidazole	30 in 1 BOTTLE	TABLET	30	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0202-0	EA - Each	50090-0202	e1c0ae35-69a5-44d9-9eba-041d195cec90	1	2021-05-05
50090-0202-1	EA - Each	50090-0202	c7d8bf71-2c2e-4301-bea6-cc7ff4663fc8	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0202	METRONIDAZOLE TABLET [A-S MEDICATION SOLUTIONS]	26	Legacy NDC, 3 package rows	20210415_abc82bde-a38a-4fa2-a7be-89bb03ede066.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	ca450fad-0513-4c45-8ea0-1f46bcbf6a36	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070027 application number: ANDA070027
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	ea635d05-b3c1-4f49-ace2-d091c20920da	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070027 application number: ANDA070027
Metronidazole	METRONIDAZOLE	Teva Pharmaceuticals USA, Inc.	291a45f6-ed27-4dcc-8364-358d08623797	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070027 application number: ANDA070027
Metronidazole	METRONIDAZOLE	Proficient Rx LP	205054e1-8172-47dc-931c-a18a60e7e9f0	2022-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070027 application number: ANDA070027

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	abc82bde-a38a-4fa2-a7be-89bb03ede066	26
314106	metronidazole 250 MG Oral Tablet	SCD	abc82bde-a38a-4fa2-a7be-89bb03ede066	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0202-2	50090020202	30 TABLET in 1 BOTTLE (50090-0202-2)	30 tablet	2019-11-14	0000-00-00	No	No	Current