Home NDC 59651-784 Cephalexin
Product NDC 59651-784
11-digit product format 596510784
Labeler code 59651
Product ID 59651-784_e46059e1-3ce9-4a3c-80ce-464b140600ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cephalexin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA218817
Marketing category ANDA
Marketing start 2024-09-27
Substance CEPHALEXIN
Active strength 500 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [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 42 .
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 A218817-001 CEPHALEXIN CEPHALEXIN EQ 250MG BASE TABLET / ORAL AB 2024-09-27 A218817-002 CEPHALEXIN CEPHALEXIN EQ 500MG BASE TABLET / ORAL AB 2024-09-27
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 2026-08-18 06:07:40 2026-07 A218817-001 CEPHALEXIN EQ 250MG BASE TABLET / ORAL AB 2024-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218817-002 CEPHALEXIN EQ 500MG BASE TABLET / ORAL AB 2024-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218817-001 CEPHALEXIN EQ 250MG BASE TABLET / ORAL AB 2024-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218817-002 CEPHALEXIN EQ 500MG BASE TABLET / ORAL AB 2024-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218817-001 CEPHALEXIN EQ 250MG BASE TABLET / ORAL AB 2024-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218817-002 CEPHALEXIN EQ 500MG BASE TABLET / ORAL AB 2024-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218817-001 CEPHALEXIN EQ 250MG BASE TABLET / ORAL AB 2024-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218817-002 CEPHALEXIN EQ 500MG BASE TABLET / ORAL AB 2024-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218817-001 CEPHALEXIN EQ 250MG BASE TABLET / ORAL AB 2024-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218817-002 CEPHALEXIN EQ 500MG BASE TABLET / ORAL AB 2024-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218817-001 CEPHALEXIN EQ 250MG BASE TABLET / ORAL AB 2024-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218817-002 CEPHALEXIN EQ 500MG BASE TABLET / ORAL AB 2024-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218817-001 CEPHALEXIN EQ 250MG BASE TABLET / ORAL AB 2024-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218817-002 CEPHALEXIN EQ 500MG BASE TABLET / ORAL AB 2024-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218817-001 CEPHALEXIN EQ 250MG BASE TABLET / ORAL AB 2024-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218817-002 CEPHALEXIN EQ 500MG BASE TABLET / ORAL AB 2024-09-27 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218817-001 CEPHALEXIN EQ 250MG BASE TABLET / ORAL AB 2024-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218817-002 CEPHALEXIN EQ 500MG BASE TABLET / ORAL AB 2024-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218817-001 CEPHALEXIN EQ 250MG BASE TABLET / ORAL AB 2024-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218817-002 CEPHALEXIN EQ 500MG BASE TABLET / ORAL AB 2024-09-27 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218817-001 CEPHALEXIN EQ 250MG BASE TABLET / ORAL AB 2024-09-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218817-002 CEPHALEXIN EQ 500MG BASE TABLET / ORAL AB 2024-09-27 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218817-001 CGT 2025-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218817-002 CGT 2025-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218817-001 CGT 2025-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218817-002 CGT 2025-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218817-001 CGT 2025-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218817-002 CGT 2025-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218817-001 CGT 2025-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218817-002 CGT 2025-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218817-001 CGT 2025-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218817-002 CGT 2025-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218817-001 CGT 2025-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218817-002 CGT 2025-04-09 2680178bc6a6…
Additional Listing Data#
Finished product Yes
Brand name base Cephalexin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEPHALEXIN 500 mg/1
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 197454 Internal RxNorm lookup 309115 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 59651-784-01 Cephalexin 100 in 1 BOTTLE TABLET, FILM COATED 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-784 CEPHALEXIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 Current NDC, 1 package rows 20241003_e46059e1-3ce9-4a3c-80ce-464b140600ce.zip
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 Marketing start Sample Exclude flag Status 59651-784-01 59651078401 100 TABLET, FILM COATED in 1 BOTTLE (59651-784-01) 2024-09-27 No No Current