Home NDC 52959-031 Cephalexin
Product NDC 52959-031
11-digit product format 529590031
Labeler code 52959
Product ID 52959-031_749fe83a-d77e-46c1-8f31-6f318af9a2da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cephalexin
Dosage form CAPSULE
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA065215
Marketing category ANDA
Marketing start 2006-02-01
Marketing end 0000-00-00
Substance CEPHALEXIN
Active strength 500 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 7 · 396 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A065215-001 CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 A065215-002 CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24
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 · 88 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 2026-10-15 13:18:30 2026-09 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 2006-01-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 2006-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2006-01-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2006-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2006-01-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2006-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2006-01-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2006-01-24 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 48 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 52959-031-00 CEPHALEXIN CAPSULES, USP 52959-031-02 CEPHALEXIN CAPSULES, USP 52959-031-04 CEPHALEXIN CAPSULES, USP 52959-031-06 CEPHALEXIN CAPSULES, USP 52959-031-08 CEPHALEXIN CAPSULES, USP 52959-031-10 CEPHALEXIN CAPSULES, USP 52959-031-12 CEPHALEXIN CAPSULES, USP 52959-031-14 CEPHALEXIN CAPSULES, USP 52959-031-15 CEPHALEXIN CAPSULES, USP 52959-031-20 CEPHALEXIN CAPSULES, USP 52959-031-21 CEPHALEXIN CAPSULES, USP 52959-031-24 CEPHALEXIN CAPSULES, USP 52959-031-28 CEPHALEXIN CAPSULES, USP 52959-031-30 CEPHALEXIN CAPSULES, USP 52959-031-40 CEPHALEXIN CAPSULES, USP 52959-031-56 CEPHALEXIN CAPSULES, USP 52959-031-60 CEPHALEXIN CAPSULES, USP
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52959-031-00 Cephalexin 100 in 1 BOTTLE, PLASTIC CAPSULE 100 3 52959-031-02 Cephalexin 120 in 1 BOTTLE, PLASTIC CAPSULE 120 3 52959-031-04 Cephalexin 4 in 1 BOTTLE, PLASTIC CAPSULE 4 3 52959-031-06 Cephalexin 6 in 1 BOTTLE, PLASTIC CAPSULE 6 3 52959-031-08 Cephalexin 8 in 1 BOTTLE, PLASTIC CAPSULE 8 3 52959-031-10 Cephalexin 500 in 1 BOTTLE, PLASTIC CAPSULE 500 3 52959-031-12 Cephalexin 12 in 1 BOTTLE, PLASTIC CAPSULE 12 3 52959-031-14 Cephalexin 14 in 1 BOTTLE, PLASTIC CAPSULE 14 3 52959-031-15 Cephalexin 15 in 1 BOTTLE, PLASTIC CAPSULE 15 3 52959-031-20 Cephalexin 20 in 1 BOTTLE, PLASTIC CAPSULE 20 3 52959-031-21 Cephalexin 21 in 1 BOTTLE, PLASTIC CAPSULE 21 3 52959-031-24 Cephalexin 24 in 1 BOTTLE, PLASTIC CAPSULE 24 3 52959-031-28 Cephalexin 28 in 1 BOTTLE, PLASTIC CAPSULE 28 3 52959-031-30 Cephalexin 30 in 1 BOTTLE, PLASTIC CAPSULE 30 3 52959-031-40 Cephalexin 40 in 1 BOTTLE, PLASTIC CAPSULE 40 3 52959-031-56 Cephalexin 56 in 1 BOTTLE, PLASTIC CAPSULE 56 3 52959-031-60 Cephalexin 60 in 1 BOTTLE, PLASTIC CAPSULE 60 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-031 CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.] 3 Legacy NDC, 17 package rows 20111227_effe46a4-c383-4171-8ab4-2af9de316f08.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-031-00 52959003100 100 in 1 BOTTLE, PLASTIC Historical 52959-031-02 52959003102 120 in 1 BOTTLE, PLASTIC Historical 52959-031-04 52959003104 4 in 1 BOTTLE, PLASTIC Historical 52959-031-06 52959003106 6 in 1 BOTTLE, PLASTIC Historical 52959-031-08 52959003108 8 in 1 BOTTLE, PLASTIC Historical 52959-031-10 52959003110 500 in 1 BOTTLE, PLASTIC Historical 52959-031-12 52959003112 12 in 1 BOTTLE, PLASTIC Historical 52959-031-14 52959003114 14 in 1 BOTTLE, PLASTIC Historical 52959-031-15 52959003115 15 in 1 BOTTLE, PLASTIC Historical 52959-031-20 52959003120 20 in 1 BOTTLE, PLASTIC Historical 52959-031-21 52959003121 21 in 1 BOTTLE, PLASTIC Historical 52959-031-24 52959003124 24 in 1 BOTTLE, PLASTIC Historical 52959-031-28 52959003128 28 in 1 BOTTLE, PLASTIC Historical 52959-031-30 52959003130 30 in 1 BOTTLE, PLASTIC Historical 52959-031-40 52959003140 40 in 1 BOTTLE, PLASTIC Historical 52959-031-56 52959003156 56 in 1 BOTTLE, PLASTIC Historical 52959-031-60 52959003160 60 in 1 BOTTLE, PLASTIC Historical