Home NDC 42043-142 Cephalexin
Product NDC 42043-142
11-digit product format 420430142
Labeler code 42043
Product ID 42043-142_63242ddf-3c2f-4f74-b95e-dd29cafa8f84
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cephalexin
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler OrchidPharma Inc
Application ANDA065326
Marketing category ANDA
Marketing start 2007-04-12
Marketing end 2020-05-31
Substance CEPHALEXIN
Active strength 125 mg/5mL
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 1 .
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 A065326-001 CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 A065326-002 CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2006-07-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065326-001 CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065326-002 CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2006-07-10 782e0a99824c…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEPHALEXIN ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC] 9 CEPHALEXIN ANHYDROUS ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC] 9 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC] 9 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC] 9 SUCROSE INACTIVE INGREDIENT C151H8M554 CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC] 9 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC] 9 CEPHALEXIN ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC] 2 CEPHALEXIN ANHYDROUS ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC] 2 CEPHALEXIN ACTIVE INGREDIENT OBN7UDS42Y CEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] 1 CEPHALEXIN ANHYDROUS ACTIVE MOIETY 5SFF1W6677 CEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] 1
DailyMed RxNorm Mappings#