Home NDC 69778-931 Cephalexin
Product NDC 69778-931
11-digit product format 697780931
Labeler code 69778
Product ID 69778-931_5f2379e6-9041-4de6-83a2-f63fa36db0d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cephalexin
Dosage form CAPSULE
Route ORAL
Labeler Pharma-C, Inc.
Application ANDA065152
Marketing category ANDA
Marketing start 2010-10-15
Substance CEPHALEXIN
Active strength 500 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Cephalexin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEPHALEXIN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OBN7UDS42Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309112 Internal RxNorm lookup 309114 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69778-931-04 Cephalexin 500 in 1 BOTTLE, PLASTIC CAPSULE 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69778-931 CEPHALEXIN CAPSULE [PHARMA-C, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20161209_bf9a6c06-11fd-4fb7-9cf5-e8e787758c1c.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69778-931-04 69778093104 500 CAPSULE in 1 BOTTLE, PLASTIC (69778-931-04) 500 capsule 2016-10-11 0000-00-00 No No Current