metronidazole vaginal

Product NDC: 45802-139
11-digit product format: 458020139
Labeler code: 45802
Product ID: 45802-139_ac51fedf-e650-40c6-a92f-d33d6f32e54b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: GEL
Route: VAGINAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA211786
Marketing category: ANDA
Marketing start: 2019-07-08
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
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 · 42 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
2026-08-18 06:07:40	2026-07	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211786-001	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: metronidazole vaginal
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 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
eb240e7b-cec8-497b-8a49-7ed768e2b431	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-139-70	metronidazole vaginal	70 g in 1 TUBE	GEL	70		3
45802-139-70	metronidazole vaginal	1 in 1 CARTON	GEL	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-139-70	GM - Gram	45802-139	4007e3c0-76ee-429e-b9ce-4338d4472e1f	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-139	METRONIDAZOLE VAGINAL (METRONIDAZOLE) GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD]	3	Current NDC, Legacy NDC, 2 package rows	20230728_eb240e7b-cec8-497b-8a49-7ed768e2b431.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 · 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
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 ndc (product): 45802-139

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
142046	metroNIDAZOLE 0.75 % Vaginal Gel	PSN	58ce793b-9b6a-4cd7-94ae-215dbf9e2ef7	7
142046	metronidazole 0.0075 MG/MG Vaginal Gel	SCD	58ce793b-9b6a-4cd7-94ae-215dbf9e2ef7	7
142046	metronidazole 0.75 % Vaginal Gel	SY	58ce793b-9b6a-4cd7-94ae-215dbf9e2ef7	7
142046	metroNIDAZOLE 0.75 % Vaginal Gel	PSN	eb240e7b-cec8-497b-8a49-7ed768e2b431	3
142046	metronidazole 0.0075 MG/MG Vaginal Gel	SCD	eb240e7b-cec8-497b-8a49-7ed768e2b431	3
142046	metronidazole 0.75 % Vaginal Gel	SY	eb240e7b-cec8-497b-8a49-7ed768e2b431	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-139-70	45802013970	1 TUBE in 1 CARTON (45802-139-70) / 70 g in 1 TUBE	1 tube	2019-07-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Vaginal Gel, 0.75%	REMEDYREPACK INC.	2026-02-13	HUMAN PRESCRIPTION DRUG LABEL	13
Metronidazole Vaginal Gel, 0.75%	A-S Medication Solutions	2025-10-29	HUMAN PRESCRIPTION DRUG LABEL	7
Metronidazole Vaginal Gel, 0.75%	RPK Pharmaceuticals, Inc.	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole Vaginal Gel, 0.75%	Bryant Ranch Prepack	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	105
Metronidazole Vaginal Gel, 0.75%	Padagis Israel Pharmaceuticals Ltd	2023-07-25	HUMAN PRESCRIPTION DRUG LABEL	3