Home NDC 46708-435 Metronidazole
Product NDC 46708-435
11-digit product format 467080435
Labeler code 46708
Product ID 46708-435_73035cba-781b-4d60-80bb-8f8ff273a0a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form CAPSULE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA079065
Marketing category ANDA
Marketing start 2016-12-09
Substance METRONIDAZOLE
Active strength 375 mg/1
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 A079065-001 METRONIDAZOLE METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079065-001 AB
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 A079065-001 METRONIDAZOLE 375MG CAPSULE / ORAL AB 2009-06-23 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 A079065-001 AB 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 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Metronidazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METRONIDAZOLE 375 mg/1
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 199055 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-435-30 Metronidazole 30 in 1 BOTTLE CAPSULE 30 3 46708-435-31 Metronidazole 100 in 1 BOTTLE CAPSULE 100 3 46708-435-50 Metronidazole 50 in 1 BOTTLE CAPSULE 50 3 46708-435-71 Metronidazole 500 in 1 BOTTLE CAPSULE 500 3 46708-435-91 Metronidazole 1000 in 1 BOTTLE CAPSULE 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-435 METRONIDAZOLE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 5 package rows 20230202_387053e5-7eda-4282-b58a-5789430a2e99.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46708-435-30 46708043530 30 CAPSULE in 1 BOTTLE (46708-435-30) 30 capsule 2016-12-09 0000-00-00 No No Current 46708-435-31 46708043531 100 CAPSULE in 1 BOTTLE (46708-435-31) 100 capsule 2016-12-09 0000-00-00 No No Current 46708-435-50 46708043550 50 CAPSULE in 1 BOTTLE (46708-435-50) 50 capsule 2016-12-09 0000-00-00 No No Current 46708-435-71 46708043571 500 CAPSULE in 1 BOTTLE (46708-435-71) 500 capsule 2016-12-09 0000-00-00 No No Current 46708-435-91 46708043591 1000 CAPSULE in 1 BOTTLE (46708-435-91) 1000 capsule 2016-12-09 0000-00-00 No No Current