Metronidazole

Product NDC: 50090-7160
11-digit product format: 500907160
Labeler code: 50090
Product ID: 50090-7160_54ce71c2-b878-455c-83b0-70525d10695a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: GEL
Route: VAGINAL
Labeler: A-S Medication Solutions
Application: ANDA215794
Marketing category: ANDA
Marketing start: 2022-06-24
Substance: METRONIDAZOLE
Active strength: 7.5 mg/g
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
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
A215794-001	METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB		2022-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215794-001	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	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`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	A215794-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215794-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215794-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215794-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215794-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215794-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215794-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215794-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215794-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215794-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215794-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215794-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215794-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215794-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215794-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215794-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215794-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215794-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215794-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215794-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215794-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215794-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215794-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215794-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215794-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215794-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215794-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215794-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215794-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215794-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215794-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215794-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215794-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METRONIDAZOLE	7.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
140QMO216E	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9d41a8b3-b8cc-4fb6-9813-d3bfa048ed78	Available on FDA.report

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
50090-7160-0	GM - Gram	50090-7160	0d25f973-628d-4448-85fd-93a85dcf345f	1	2024-06-10

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	Northstar Rx LLC	65cda174-d840-488a-96d0-74d6086b7048	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215794 application number: ANDA215794
Metronidazole	METRONIDAZOLE	GLENMARK PHARMACEUTICALS INC., USA	6736c100-a7fe-44ea-8579-5537537ff9b8	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215794 application number: ANDA215794
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	e6ece591-38fa-4016-bd62-d31a3e5a8da3	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215794 application number: ANDA215794
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	9d41a8b3-b8cc-4fb6-9813-d3bfa048ed78	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215794 application number: ANDA215794 ndc (product): 50090-7160

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	Marketing start	Sample	Exclude flag	Status
50090-7160-0	50090716000	1 TUBE, WITH APPLICATOR in 1 CARTON (50090-7160-0) / 70 g in 1 TUBE, WITH APPLICATOR	2024-05-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Vaginal Gel, 0.75%	A-S Medication Solutions	2024-05-06	HUMAN PRESCRIPTION DRUG LABEL	1