Metronidazole

Product NDC: 70518-4495
11-digit product format: 705184495
Labeler code: 70518
Product ID: 70518-4495_5b72f53d-b858-bb90-e063-6294a90a89e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: GEL
Route: VAGINAL
Labeler: REMEDYREPACK INC.
Application: ANDA213648
Marketing category: ANDA
Marketing start: 2025-10-10
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: Metronidazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METRONIDAZOLE	7.5 mg/g

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4495-0	Metronidazole	70 g in 1 TUBE, WITH APPLICATOR	GEL	70		1
70518-4495-0	Metronidazole	1 in 1 CARTON	GEL	1		1

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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
142046	metroNIDAZOLE 0.75 % Vaginal Gel	PSN	2a6f8d77-a5b7-40fb-9a2e-e2778c39ba01	1
142046	metronidazole 0.0075 MG/MG Vaginal Gel	SCD	2a6f8d77-a5b7-40fb-9a2e-e2778c39ba01	1
142046	metronidazole 0.75 % Vaginal Gel	SY	2a6f8d77-a5b7-40fb-9a2e-e2778c39ba01	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4495-0	70518449500	1 TUBE, WITH APPLICATOR in 1 CARTON (70518-4495-0) / 70 g in 1 TUBE, WITH APPLICATOR	2025-10-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Vaginal Gel, 0.75% FOR INTRAVAGINAL USE ONLY NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE	REMEDYREPACK INC.	2026-09-14	HUMAN PRESCRIPTION DRUG LABEL	3