Home NDC 10544-503 Cephalexin
Product NDC 10544-503
11-digit product format 105440503
Labeler code 10544
Product ID 10544-503_7d7a65bd-ef86-4b09-94c2-a26c1aa2b227
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cephalexin
Dosage form CAPSULE
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA065248
Marketing category ANDA
Marketing start 2009-12-22
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 3 · 132 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 A065248-001 CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 A065248-002 CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28
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 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065248-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-06-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065248-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-06-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 10544-503-14 CEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 10544-503-20 CEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 10544-503-28 CEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 10544-503-30 CEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 10544-503-40 CEPHALEXIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, 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 10544-503-14 Cephalexin 14 in 1 BOTTLE CAPSULE 14 1 10544-503-20 Cephalexin 20 in 1 BOTTLE CAPSULE 20 1 10544-503-28 Cephalexin 28 in 1 BOTTLE CAPSULE 28 1 10544-503-30 Cephalexin 30 in 1 BOTTLE CAPSULE 30 1 10544-503-40 Cephalexin 40 in 1 BOTTLE CAPSULE 40 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEPHALEXIN ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 CEPHALEXIN ANHYDROUS ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-503 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 5 package rows 20100913_d5baab72-2d4b-42aa-973e-860a22b23a90.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-503-14 10544050314 14 in 1 BOTTLE Historical 10544-503-20 10544050320 20 in 1 BOTTLE Historical 10544-503-28 10544050328 28 in 1 BOTTLE Historical 10544-503-30 10544050330 30 in 1 BOTTLE Historical 10544-503-40 10544050340 40 in 1 BOTTLE Historical