MetroGel-Vaginal

Product NDC: 99207-130
11-digit product format: 992070130
Labeler code: 99207
Product ID: 99207-130_c08e30fc-ad8b-4bc0-ab9f-644021a906bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: GEL
Route: VAGINAL
Labeler: Medicis Pharmaceutical Corp
Application: NDA020208
Marketing category: NDA
Marketing start: 2011-11-28
Marketing end: 0000-00-00
Substance: METRONIDAZOLE
Active strength: 8 mg/g
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	99207-130		D	Discontinued by firm		2026-07-31
excluded package	package	99207-130	99207-130-70	D	Discontinued by firm		2026-07-31

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.

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
2026-08-01 22:54:32	2026-06	N020208-001	METROGEL-VAGINAL	0.75%	GEL / VAGINAL		RLD	1992-08-17	`a50c72e98297…`

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 · 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
99207-130-70	GM - Gram	99207-130	6c91129e-278e-4d7e-ad08-a1fbd50c01f7	1	2012-07-24