Home NDC 61442-162 Cephalexin
Product NDC 61442-162
11-digit product format 614420162
Labeler code 61442
Product ID 61442-162_af92ea41-b5dd-433d-9c09-b103240f2853
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cephalexin
Dosage form CAPSULE
Route ORAL
Labeler Carlsbad Technology, Inc.
Application ANDA065152
Marketing category ANDA
Marketing start 2010-10-15
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 2 · 63 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A065152-001 CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 A065152-002 CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24
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 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Cephalexin ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Cephalexin Anhydrous ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Alcohol INACTIVE INGREDIENT 3K9958V90M CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Ammonia INACTIVE INGREDIENT 5138Q19F1X CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Butyl Alcohol INACTIVE INGREDIENT 8PJ61P6TS3 CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Colloidal Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 FD&C Yellow No. 5 INACTIVE INGREDIENT I753WB2F1M CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Ferrosoferric Oxide INACTIVE INGREDIENT XM0M87F357 CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Gelatin INACTIVE INGREDIENT 2G86QN327L CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Isopropyl Alcohol INACTIVE INGREDIENT ND2M416302 CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Lactose INACTIVE INGREDIENT J2B2A4N98G CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Potassium Hydroxide INACTIVE INGREDIENT WZH3C48M4T CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Shellac INACTIVE INGREDIENT 46N107B71O CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Sodium Starch Glycolate Type A Potato INACTIVE INGREDIENT 5856J3G2A2 CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Talc INACTIVE INGREDIENT 7SEV7J4R1U CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Water INACTIVE INGREDIENT 059QF0KO0R CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Cephalexin ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Cephalexin Anhydrous ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Alcohol INACTIVE INGREDIENT 3K9958V90M CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Ammonia INACTIVE INGREDIENT 5138Q19F1X CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Butyl Alcohol INACTIVE INGREDIENT 8PJ61P6TS3 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Colloidal Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FD&C Yellow No. 5 INACTIVE INGREDIENT I753WB2F1M CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Ferrosoferric Oxide INACTIVE INGREDIENT XM0M87F357 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Gelatin INACTIVE INGREDIENT 2G86QN327L CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Isopropyl Alcohol INACTIVE INGREDIENT ND2M416302 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Lactose INACTIVE INGREDIENT J2B2A4N98G CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Potassium Hydroxide INACTIVE INGREDIENT WZH3C48M4T CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Shellac INACTIVE INGREDIENT 46N107B71O CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Sodium Starch Glycolate Type A Potato INACTIVE INGREDIENT 5856J3G2A2 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Talc INACTIVE INGREDIENT 7SEV7J4R1U CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61442-162 CEPHALEXIN CAPSULE [CARLSBAD TECHNOLOGY, INC.] 8 Legacy NDC 20140508_7ae019f7-ae75-4a5a-a7a7-38cb0992c127.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.
DailyMed RxNorm Mappings#