Home NDC 69543-102 Cephalexin
Product NDC 69543-102
11-digit product format 695430102
Labeler code 69543
Product ID 69543-102_b35b6662-11c3-435e-9cae-12ed3dcd15b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cephalexin
Dosage form CAPSULE
Route ORAL
Labeler Virtus Pharmaceuticals
Application ANDA062713
Marketing category ANDA
Marketing start 2015-06-02
Marketing end 2020-11-30
Substance CEPHALEXIN
Active strength 500 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 A062713-001 CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 A062713-002 CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15
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 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062713-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 1988-07-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062713-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 1988-07-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 [DIRECTRX] 2 CEPHALEXIN ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 2 CEPHALEXIN ANHYDROUS ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 2 CEPHALEXIN ANHYDROUS ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN CAPSULE [DIRECTRX] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 2 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK CEPHALEXIN CAPSULE [DIRECTRX] 2 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 CEPHALEXIN CAPSULE [DIRECTRX] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 2 gelatin INACTIVE INGREDIENT 2G86QN327L CEPHALEXIN CAPSULE [DIRECTRX] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CEPHALEXIN CAPSULE [DIRECTRX] 2 talc INACTIVE INGREDIENT 7SEV7J4R1U CEPHALEXIN CAPSULE [DIRECTRX] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP CEPHALEXIN CAPSULE [DIRECTRX] 2 cephalexin ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN CAPSULE [VIRTUS PHARMACEUTICALS] 1 cephalexin anhydrous ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN CAPSULE [VIRTUS PHARMACEUTICALS] 1 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK CEPHALEXIN CAPSULE [VIRTUS PHARMACEUTICALS] 1 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 CEPHALEXIN CAPSULE [VIRTUS PHARMACEUTICALS] 1 gelatin INACTIVE INGREDIENT 2G86QN327L CEPHALEXIN CAPSULE [VIRTUS PHARMACEUTICALS] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CEPHALEXIN CAPSULE [VIRTUS PHARMACEUTICALS] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U CEPHALEXIN CAPSULE [VIRTUS PHARMACEUTICALS] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP CEPHALEXIN CAPSULE [VIRTUS PHARMACEUTICALS] 1
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#