Home NDC 31722-865-25 Linezolid
Product NDC 31722-865
Requested package NDC 31722-865-25
11-digit product format 317220865
Labeler code 31722
Product ID 31722-865_05657697-e108-9eaf-e063-6294a90a5d97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Linezolid
Dosage form GRANULE, FOR SUSPENSION
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA211813
Marketing category ANDA
Marketing start 2022-10-31
Substance LINEZOLID
Active strength 100 mg/5mL
Pharmacologic classes Oxazolidinone Antibacterial [EPC], Oxazolidinones [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 A211813-001 LINEZOLID LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211813-001 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 A211813-001 LINEZOLID 100MG/5ML FOR SUSPENSION / ORAL AB 2022-10-31 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 A211813-001 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 Linezolid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LINEZOLID 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ISQ9I6J12J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311345 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 31722-865-25 Linezolid 150 mL in 1 BOTTLE, GLASS GRANULE, FOR SUSPENSION 150 2 31722-865-25 Linezolid 1 in 1 CARTON GRANULE, FOR SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-865 LINEZOLID (LINEZOLID) GRANULE, FOR SUSPENSION [CAMBER PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20230926_a89a37ec-a736-464b-a83a-84bef6ccd702.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 31722-865-25 31722086525 1 BOTTLE, GLASS in 1 CARTON (31722-865-25) / 150 mL in 1 BOTTLE, GLASS 2022-10-31 0000-00-00 No No Current