Metronidazole

Product NDC: 68682-455
Requested package NDC: 68682-455-70
11-digit product format: 686820455
Labeler code: 68682
Product ID: 68682-455_25ae84b0-f8f3-41c3-b5ff-477624171706
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: GEL
Route: VAGINAL
Labeler: Oceanside Pharmaceuticals
Application: NDA020208
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-04-01
Marketing end: 2026-07-31
Substance: METRONIDAZOLE
Active strength: 7.5 mg/g
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68682-455	68682-455-70	D	Discontinued by firm		2026-08-03

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
N020208-001	METROGEL-VAGINAL	METRONIDAZOLE	0.75%	GEL / VAGINAL		RLD	1992-08-17

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL		RLD	1992-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL		RLD	1992-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL	AB	RLD, RS	1992-08-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N020208-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020208-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020208-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020208-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020208-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020208-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020208-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020208-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020208-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020208-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020208-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020208-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020208-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020208-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020208-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020208-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020208-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020208-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020208-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020208-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020208-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020208-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020208-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020208-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020208-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020208-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020208-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020208-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020208-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020208-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020208-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020208-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020208-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020208-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020208-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020208-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020208-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020208-001	AB	1	`cb3db0bc1861…`

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
68682-455-70	Metronidazole	1 in 1 CARTON	GEL	1		8
68682-455-70	Metronidazole	70 g in 1 TUBE, WITH APPLICATOR	GEL	70		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-455-70	GM - Gram	68682-455	fef357a2-46d3-4f90-b311-2ebf6e70b1cb	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS]	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS]	1
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-455	METRONIDAZOLE GEL [OCEANSIDE PHARMACEUTICALS]	7	Current NDC, Legacy NDC, 2 package rows	20230510_526c226a-099b-4eb3-943d-c88b2763b2c1.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	8b2c294b-ed70-447c-bbc4-2a8b59f1aca4	2023-10-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020208 application number: NDA020208

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	8b2c294b-ed70-447c-bbc4-2a8b59f1aca4	10
142046	metronidazole 0.0075 MG/MG Vaginal Gel	SCD	8b2c294b-ed70-447c-bbc4-2a8b59f1aca4	10
142046	metronidazole 0.75 % Vaginal Gel	SY	8b2c294b-ed70-447c-bbc4-2a8b59f1aca4	10
142046	metroNIDAZOLE 0.75 % Vaginal Gel	PSN	526c226a-099b-4eb3-943d-c88b2763b2c1	8
142046	metronidazole 0.0075 MG/MG Vaginal Gel	SCD	526c226a-099b-4eb3-943d-c88b2763b2c1	8
142046	metronidazole 0.75 % Vaginal Gel	SY	526c226a-099b-4eb3-943d-c88b2763b2c1	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-455-70	68682045570	1 TUBE, WITH APPLICATOR in 1 CARTON (68682-455-70) / 70 g in 1 TUBE, WITH APPLICATOR	2015-04-01	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Vaginal Gel, 0.75%	RPK Pharmaceuticals, Inc.	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole Vaginal Gel, 0.75%	A-S Medication Solutions	2023-10-25	HUMAN PRESCRIPTION DRUG LABEL	10
Metronidazole Vaginal Gel, 0.75%	NuCare Pharmaceuticals,Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole Vaginal Gel, 0.75%	Oceanside Pharmaceuticals \| DPT Laboratories, Ltd.	2020-10-31	HUMAN PRESCRIPTION DRUG LABEL	8