Vagizole

Product NDC: 87687-002
Requested package NDC: 87687-002-70
11-digit product format: 876870002
Labeler code: 87687
Product ID: 87687-002_573f6126-ffbe-f46f-e063-6394a90abf65
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: GEL
Route: VAGINAL
Labeler: iNutrition LLC
Application: ANDA213648
Marketing category: ANDA
Marketing start: 2026-06-29
Substance: METRONIDAZOLE
Active strength: 7.5 mg/g
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A213648-001	METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB		2021-10-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213648-001	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
2026-09-14 22:38:34	2026-08	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213648-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2021-10-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213648-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213648-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213648-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213648-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213648-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213648-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213648-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213648-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213648-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213648-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213648-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213648-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213648-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213648-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213648-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213648-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213648-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213648-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213648-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213648-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213648-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213648-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213648-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213648-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213648-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213648-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213648-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213648-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213648-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213648-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213648-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213648-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213648-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213648-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213648-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Vagizole
Listing expiration: 2027-12-31

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
142046	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
fd5e884b-cf07-493b-bb93-039bbb0c4784	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vagizole	METRONIDAZOLE	iNutrition LLC	fd5e884b-cf07-493b-bb93-039bbb0c4784	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213648 application number: ANDA213648 ndc (package): 87687-002-70 ndc (product): 87687-002 ndc11 (package): 87687000270
Metronidazole	METRONIDAZOLE	Solaris Pharma Corporation	94a83daa-6e34-419d-849a-6f18d3b8c586	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213648 application number: ANDA213648

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
87687-002-70	87687000270	1 TUBE, WITH APPLICATOR in 1 CARTON (87687-002-70) / 70 g in 1 TUBE, WITH APPLICATOR	2026-06-29	No	No	Current