Home NDC 70518-4759 Cefixime
Product NDC 70518-4759
11-digit product format 705184759
Labeler code 70518
Product ID 70518-4759_5c114a0a-eb6c-507a-e063-6294a90a8231
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefixime
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA217607
Marketing category ANDA
Marketing start 2026-09-21
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 43 .
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 2026-09-14 22:38:34 2026-08 A217607-001 CEFIXIME 400MG CAPSULE / ORAL AB 2026-03-23 84e616aacf4f…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 2026-09-14 22:38:34 2026-08 A217607-001 AB 1 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cefixime CEFIXIME Aurobindo Pharma Limited 9cdb156f-7a99-413e-b49a-ffafaf9e93fe 2026-03-25 Warnings, Adverse reactions Exact identifier application applno (ANDA): 217607 application number: ANDA217607
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4759-0 70518475900 2 CAPSULE in 1 BOTTLE, PLASTIC (70518-4759-0) 2 capsule 2026-09-21 No No Current