metronidazole vaginal

Product NDC: 70518-2814
Requested package NDC: 70518-2814-0
11-digit product format: 705182814
Labeler code: 70518
Product ID: 70518-2814_4ab61a1a-01ac-1dfa-e063-6294a90a4d37
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: GEL
Route: VAGINAL
Labeler: REMEDYREPACK INC.
Application: ANDA211786
Marketing category: ANDA
Marketing start: 2020-07-14
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 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
A211786-001	METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB		2019-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211786-001	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	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`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	A211786-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211786-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211786-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211786-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211786-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211786-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211786-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211786-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211786-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211786-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211786-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211786-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211786-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211786-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211786-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211786-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211786-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211786-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211786-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211786-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211786-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211786-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211786-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211786-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211786-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211786-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211786-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211786-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211786-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211786-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211786-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211786-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211786-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211786-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211786-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211786-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211786-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211786-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211786-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211786-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
metronidazole vaginal	METRONIDAZOLE	REMEDYREPACK INC.	b8fbd105-90ae-4af4-9313-61834aaf4a2c	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211786 application number: ANDA211786 ndc (package): 70518-2814-0 ndc (product): 70518-2814 ndc11 (package): 70518281400
metronidazole vaginal	METRONIDAZOLE	A-S Medication Solutions	58ce793b-9b6a-4cd7-94ae-215dbf9e2ef7	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211786 application number: ANDA211786
metronidazole vaginal	METRONIDAZOLE	Padagis Israel Pharmaceuticals Ltd	eb240e7b-cec8-497b-8a49-7ed768e2b431	2023-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211786 application number: ANDA211786

Additional Listing Data#

Finished product: Yes
Brand name base: metronidazole vaginal
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
b8fbd105-90ae-4af4-9313-61834aaf4a2c	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2814-0	2022-02-04	C162847	48780-1	d6a99b39-7f0c-a426-e053-dadaa90af4c2	Metronidazole Vaginal Gel, 0.75%
70518-2814-0	2022-01-28	C162847	48780-1	d6a99b39-7f0c-a426-e053-dadaa90af4c2	Metronidazole Vaginal Gel, 0.75%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-2814-0	metronidazole vaginal	70 g in 1 TUBE	GEL	70		13
70518-2814-0	metronidazole vaginal	1 in 1 CARTON	GEL	1		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2814	METRONIDAZOLE VAGINAL (METRONIDAZOLE) GEL [REMEDYREPACK INC.]	10	Current NDC, Legacy NDC, 2 package rows	20250406_b8fbd105-90ae-4af4-9313-61834aaf4a2c.zip

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	b8fbd105-90ae-4af4-9313-61834aaf4a2c	13
142046	metronidazole 0.0075 MG/MG Vaginal Gel	SCD	b8fbd105-90ae-4af4-9313-61834aaf4a2c	13
142046	metronidazole 0.75 % Vaginal Gel	SY	b8fbd105-90ae-4af4-9313-61834aaf4a2c	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2814-0	70518281400	1 TUBE in 1 CARTON (70518-2814-0) / 70 g in 1 TUBE	1 tube	2020-07-14	0000-00-00	No	No	Current