Home NDC 59651-647 Cefixime
Product NDC 59651-647
11-digit product format 596510647
Labeler code 59651
Product ID 59651-647_9cdb156f-7a99-413e-b49a-ffafaf9e93fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefixime
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA217607
Marketing category ANDA
Marketing start 2026-03-23
Substance CEFIXIME
Active strength 400 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A217607-001 CEFIXIME CEFIXIME 400MG CAPSULE / ORAL AB 2026-03-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217607-001 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 2026-08-18 06:07:40 2026-07 A217607-001 CEFIXIME 400MG CAPSULE / ORAL AB 2026-03-23 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217607-001 CEFIXIME 400MG CAPSULE / ORAL AB 2026-03-23 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A217607-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217607-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Cefixime
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFIXIME 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 97I1C92E55 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 409823 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 59651-647-10 Cefixime 1 in 1 CARTON CAPSULE 1 1 59651-647-10 Cefixime 10 in 1 BLISTER PACK CAPSULE 10 1 59651-647-50 Cefixime 50 in 1 BOTTLE CAPSULE 50 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-647-10 59651064710 1 BLISTER PACK in 1 CARTON (59651-647-10) / 10 CAPSULE in 1 BLISTER PACK 1 blister pack 2026-03-23 No No Current 59651-647-50 59651064750 50 CAPSULE in 1 BOTTLE (59651-647-50) 50 capsule 2026-03-23 No No Current