Home NDC 42254-080 cephalexin
Product NDC 42254-080
11-digit product format 422540080
Labeler code 42254
Product ID 42254-080_4511cefb-084b-4191-899c-f500091f589c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cephalexin
Dosage form CAPSULE
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA062791
Marketing category ANDA
Marketing start 2010-06-21
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 4 · 198 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A062791-001 CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 A062791-002 CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11
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 · 86 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 2026-09-14 22:38:34 2026-08 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 74a2ff9319b5…
Observed Orange Book normalized TE history# 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 42254-080-06 Cephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 42254-080-12 Cephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 42254-080-14 Cephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 42254-080-20 Cephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 42254-080-21 Cephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 42254-080-28 Cephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 42254-080-30 Cephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 42254-080-40 Cephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42254-080 CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP] 2 Legacy NDC, 8 package rows 20130329_c5604b48-d58f-45ac-8602-72241ed4b906.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 42254-080-06 42254008006 6 in 1 BOTTLE Historical 42254-080-12 42254008012 12 in 1 BOTTLE Historical 42254-080-14 42254008014 14 in 1 BOTTLE Historical 42254-080-20 42254008020 20 in 1 BOTTLE Historical 42254-080-21 42254008021 21 in 1 BOTTLE Historical 42254-080-28 42254008028 28 in 1 BOTTLE Historical 42254-080-30 42254008030 30 in 1 BOTTLE Historical 42254-080-40 42254008040 40 in 1 BOTTLE Historical