Home NDC 50436-0117 cephalexin
Product NDC 50436-0117
11-digit product format 504360117
Labeler code 50436
Product ID 50436-0117_51a8f729-cedf-4974-b630-4528f2222f5a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cephalexin
Dosage form CAPSULE
Route ORAL
Labeler Unit Dose Services
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 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 · 147 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 50436-0117-1 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. 50436-0117-2 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. 50436-0117-3 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. 50436-0117-4 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. 50436-0117-5 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. 50436-0117-8 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 50436-0117 CEPHALEXIN CAPSULE [UNIT DOSE SERVICES] 4 Legacy NDC, 6 package rows 20130502_6abc40af-be15-405e-845c-c31866b3d6f6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50436-0117-1 50436011701 28 in 1 BOTTLE Historical 50436-0117-2 50436011702 30 in 1 BOTTLE Historical 50436-0117-3 50436011703 40 in 1 BOTTLE Historical 50436-0117-4 50436011704 14 in 1 BOTTLE Historical 50436-0117-5 50436011705 20 in 1 BOTTLE Historical 50436-0117-8 50436011708 21 in 1 BOTTLE Historical