Home NDC 42291-209 Cephalexin
Product NDC 42291-209
11-digit product format 422910209
Labeler code 42291
Product ID 42291-209_d579f41e-beef-240b-e053-2995a90a8ef8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cephalexin
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA062713
Marketing category ANDA
Marketing start 2011-08-11
Marketing end 0000-00-00
Substance CEPHALEXIN
Active strength 500 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A062713-001 CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 A062713-002 CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15
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.
Product history page 1 of 3 · 84 observed 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 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cephalexin
Listing expiration 2027-12-31 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 309112 Internal RxNorm lookup 309114 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-209 CEPHALEXIN CAPSULE [AVKARE] 11 Legacy NDC 20240110_03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-209-50 42291020950 500 CAPSULE in 1 BOTTLE (42291-209-50) 500 capsule 2011-08-11 0000-00-00 No No Current