METRONIDAZOLE

Product NDC: 52584-811
11-digit product format: 525840811
Labeler code: 52584
Product ID: 52584-811_2f91b278-94b7-4d14-9add-dbeba67c3015
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METRONIDAZOLE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: General Injectables and Vaccines, Inc.
Application: NDA018890
Marketing category: NDA
Marketing start: 2018-07-02
Marketing end: 0000-00-00
Substance: METRONIDAZOLE
Active strength: 500 mg/100mL
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	52584-811		D	Discontinued by firm		2026-08-03
excluded package	package	52584-811	52584-811-24	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
N018890-002	METRONIDAZOLE IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018890-002	AP

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	N018890-002	METRONIDAZOLE IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-18	`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	N018890-002	AP	1	`a50c72e98297…`

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
140QMO216E	METRONIDAZOLE	443-48-1	METRONIDAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-811-24	52584081124	1 BAG in 1 BAG (52584-811-24) > 100 mL in 1 BAG	1 bag	2018-07-02	0000-00-00	No	No	Current