Vandazole

Product NDC: 70518-2400
11-digit product format: 705182400
Labeler code: 70518
Product ID: 70518-2400_967bdce5-060b-2bde-e053-2995a90a99bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: GEL
Route: VAGINAL
Labeler: REMEDYREPACK INC.
Application: NDA021806
Marketing category: NDA
Marketing start: 2019-11-01
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: 2020-12-31
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	70518-2400		D	Discontinued by firm		2026-07-31
excluded package	package	70518-2400	70518-2400-0	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
N021806-001	VANDAZOLE	METRONIDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021806-001	BX

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	N021806-001	VANDAZOLE	0.75%	GEL / VAGINAL	BX	RS	2005-05-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N021806-001	BX	1	`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
Vandazole	METRONIDAZOLE	Upsher-smith Laboratories, LLC	27d71471-8f89-4a1e-8c55-020a58961454	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021806 application number: NDA021806