Home NDC 0143-9897 Cephalexin
Product NDC 0143-9897
11-digit product format 001439897
Labeler code 0143
Product ID 0143-9897_05767850-451f-450d-91f1-e1fe9aa63626
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cephalexin
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA 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 No
Listing certified through 2022-12-31
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 1 · 36 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 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 · 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 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…2019-12-13 00:20 UTC 2019-12 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2006-01-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2006-01-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065215-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2006-01-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065215-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2006-01-24 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEPHALEXIN ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP] 6 CEPHALEXIN ANHYDROUS ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CEPHALEXIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP] 6 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CEPHALEXIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L CEPHALEXIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEPHALEXIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEPHALEXIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEPHALEXIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEPHALEXIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP] 6 CEPHALEXIN ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.] 3 CEPHALEXIN ANHYDROUS ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.] 3 CEPHALEXIN ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.] 1 CEPHALEXIN ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN CAPSULE [MEDVANTX, INC.] 1 CEPHALEXIN ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 CEPHALEXIN ACTIVE MOIETY OBN7UDS42Y CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.] 1 CEPHALEXIN ACTIVE MOIETY OBN7UDS42Y CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 CEPHALEXIN ANHYDROUS ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN CAPSULE [MEDVANTX, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CEPHALEXIN CAPSULE [MEDVANTX, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CEPHALEXIN CAPSULE [MEDVANTX, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L CEPHALEXIN CAPSULE [MEDVANTX, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEPHALEXIN CAPSULE [MEDVANTX, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEPHALEXIN CAPSULE [MEDVANTX, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEPHALEXIN CAPSULE [MEDVANTX, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEPHALEXIN CAPSULE [MEDVANTX, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEPHALEXIN CAPSULE [ALTURA PHARMACEUTICALS, INC.] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0143-9897-01 00143989701 100 CAPSULE in 1 BOTTLE, PLASTIC (0143-9897-01) 100 capsule 2006-02-01 0000-00-00 No No Current 0143-9897-05 00143989705 500 CAPSULE in 1 BOTTLE, PLASTIC (0143-9897-05) 500 capsule 2006-02-01 0000-00-00 No No Current