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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42043-142DDiscontinued by firm2026-08-03
excluded packagepackage42043-14242043-142-38DDiscontinued by firm2026-08-03
excluded packagepackage42043-14242043-142-58DDiscontinued by firm2026-08-03

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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42043-142-58d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42043-142-38d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42043-142-58f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42043-142-38f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42043-142-582ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42043-142-382ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42043-142-58a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42043-142-38a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42043-142-58cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42043-142-38cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42043-142-58cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42043-142-38cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42043-142-58302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42043-142-38302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42043-142-58ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42043-142-38ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42043-142-580efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42043-142-380efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42043-142-58ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42043-142-38ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42043-142-58367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42043-142-38367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42043-142-58557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42043-142-38557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065326-001CEPHALEXINCEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10
A065326-002CEPHALEXINCEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-10782e0a99824c…
2021-12-28 21:50 UTC2021-12A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-10782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-04 05:41 UTC2022-04A065326-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065326-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065326-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065326-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065326-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065326-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065326-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065326-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065326-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065326-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065326-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A065326-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065326-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A065326-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065326-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065326-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065326-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A065326-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065326-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065326-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065326-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065326-002AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dfa3f520-409c-432e-b6d3-9250d468c772Product name120250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42043-142-38ML - Milliliter42043-142ac0c071f-a9df-47ae-9445-7a034e06f64912012-07-24
42043-142-58ML - Milliliter42043-1423c0278d6-a0f7-40e3-8c90-c2b55be135ad12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]9
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]9
SUCROSEINACTIVE INGREDIENTC151H8M554CEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]9
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEPHALEXIN POWDER, FOR SUSPENSION [ORCHIDPHARMA INC]9
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554CEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEPHALEXIN POWDER, FOR SUSPENSION [STAT RX USA LLC]2
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554CEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEPHALEXIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309110cephalexin 125 MG in 5 mL Oral SuspensionPSNb5da860d-9cfc-4020-bc81-11f2a01e660b2
309113cephalexin 250 MG in 5 mL Oral SuspensionPSNb5da860d-9cfc-4020-bc81-11f2a01e660b2
309110cephalexin 25 MG/ML Oral SuspensionSCDb5da860d-9cfc-4020-bc81-11f2a01e660b2
309113cephalexin 50 MG/ML Oral SuspensionSCDb5da860d-9cfc-4020-bc81-11f2a01e660b2
309110cefalexin 25 MG/ML Oral SuspensionSYb5da860d-9cfc-4020-bc81-11f2a01e660b2
309113cefalexin 50 MG/ML Oral SuspensionSYb5da860d-9cfc-4020-bc81-11f2a01e660b2
309110cephalexin 125 MG per 5 ML Oral SuspensionSYb5da860d-9cfc-4020-bc81-11f2a01e660b2
309113cephalexin 250 MG per 5 ML Oral SuspensionSYb5da860d-9cfc-4020-bc81-11f2a01e660b2
309110cephalexin 125 MG in 5 mL Oral SuspensionPSNa00e07e9-2c16-4d3e-bb63-6fd2b05fe1b71
309110cephalexin 25 MG/ML Oral SuspensionSCDa00e07e9-2c16-4d3e-bb63-6fd2b05fe1b71
309110cefalexin 25 MG/ML Oral SuspensionSYa00e07e9-2c16-4d3e-bb63-6fd2b05fe1b71
309110cephalexin 125 MG per 5 ML Oral SuspensionSYa00e07e9-2c16-4d3e-bb63-6fd2b05fe1b71