Home NDC 0404-9991 METRONIDAZOLE
Product NDC 0404-9991
11-digit product format 004049991
Labeler code 0404
Product ID 0404-9991_1f13748c-910c-4ec8-8669-ecf7507f8320
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA206191
Marketing category ANDA
Marketing start 2023-02-24
Substance METRONIDAZOLE
Active strength 500 mg/100mL
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 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 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE 500MG/100ML INJECTABLE / INJECTION AP RS 2019-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206191-001 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 A206191-001 METRONIDAZOLE IN PLASTIC CONTAINER 500MG/100ML INJECTABLE / INJECTION AP RS 2019-02-25 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 A206191-001 AP 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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Metronidazole METRONIDAZOLE WG Critical Care, LLC e4ea0c09-cdd1-4708-962c-6ba28b989df3 2026-05-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206191 application number: ANDA206191 Metronidazole METRONIDAZOLE Hospira, Inc. 49360d6f-c8b3-420e-af75-154cf7b05255 2025-11-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206191 application number: ANDA206191 METRONIDAZOLE METRONIDAZOLE Henry Schein, Inc. df7df946-c83f-4adf-9007-aff4f757a665 2025-08-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206191 application number: ANDA206191 ndc (product): 0404-9991 Metronidazole METRONIDAZOLE Sagent Pharmaceuticals d46870f5-e2b1-46bd-8413-4a0a8bcf3175 2025-08-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206191 application number: ANDA206191
Additional Listing Data#
Finished product Yes
Brand name base METRONIDAZOLE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METRONIDAZOLE 500 mg/100mL
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 311683 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0404-9991-00 METRONIDAZOLE 100 mL in 1 BAG INJECTION, SOLUTION 100 4 0404-9991-00 METRONIDAZOLE 1 in 1 BAG INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9991 METRONIDAZOLE INJECTION, SOLUTION [HENRY SCHEIN, INC.] 3 Current NDC, 2 package rows 20240327_df7df946-c83f-4adf-9007-aff4f757a665.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0404-9991-00 00404999100 1 BAG in 1 BAG (0404-9991-00) / 100 mL in 1 BAG 1 bag 2023-02-24 No No Current