Home NDC 33261-149 cephalexin
Product NDC 33261-149
11-digit product format 332610149
Labeler code 33261
Product ID 33261-149_9e4f9fd2-cd74-4527-8b28-4688f72cdf6f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cephalexin
Dosage form CAPSULE
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
Application ANDA062791
Marketing category ANDA
Marketing start 2010-06-21
Marketing end 0000-00-00
Substance CEPHALEXIN ANHYDROUS
Active strength 250 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2019-12-31
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 3 · 126 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 2026-02-19 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…2022-03-09 01:35 UTC 2022-03 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062791-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL 1987-06-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A062791-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL 1987-06-11 782e0a99824c…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 33261-149-00 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. 33261-149-20 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. 33261-149-28 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. 33261-149-30 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. 33261-149-40 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33261-149-00 cephalexin 100 in 1 BOTTLE CAPSULE 100 3 33261-149-20 cephalexin 20 in 1 BOTTLE CAPSULE 20 3 33261-149-28 cephalexin 28 in 1 BOTTLE CAPSULE 28 3 33261-149-30 cephalexin 30 in 1 BOTTLE CAPSULE 30 3 33261-149-40 cephalexin 40 in 1 BOTTLE CAPSULE 40 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33261-149 CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC] 3 Legacy NDC, 5 package rows 20120914_cab0d668-f4a4-4848-ba93-fa2c2246096c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 33261-149-00 33261014900 100 in 1 BOTTLE Historical 33261-149-20 33261014920 20 in 1 BOTTLE Historical 33261-149-28 33261014928 28 in 1 BOTTLE Historical 33261-149-30 33261014930 30 in 1 BOTTLE Historical 33261-149-40 33261014940 40 in 1 BOTTLE Historical