Home NDC 59651-323 Cephalexin
Product NDC 59651-323
11-digit product format 596510323
Labeler code 59651
Product ID 59651-323_1a37b4f8-8f1f-4aed-9409-6c22716c5b68
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cephalexin
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA213568
Marketing category ANDA
Marketing start 2026-06-09
Substance CEPHALEXIN
Active strength 250 mg/5mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213568-001 CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2026-06-09 A213568-002 CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2026-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A213568-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2026-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213568-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2026-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213568-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2026-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213568-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2026-06-09 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213568-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2026-06-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213568-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2026-06-09 a50c72e98297…
Observed Orange Book normalized TE history# 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 Cephalexin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEPHALEXIN 250 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OBN7UDS42Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309110 Internal RxNorm lookup 309113 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-323-01 59651032301 100 mL in 1 BOTTLE (59651-323-01) 100 ml 2026-06-09 No No Current 59651-323-02 59651032302 200 mL in 1 BOTTLE (59651-323-02) 200 ml 2026-06-09 No No Current