Cephalexin

Product NDC
50090-3111
11-digit product format
500903111
Labeler code
50090
Product ID
50090-3111_4b2dc701-2bfd-4330-8c32-666e1e08cbb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065229
Marketing category
ANDA
Marketing start
2006-01-11
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3111IInactivated by FDA2026-08-10
excluded packagepackage50090-311150090-3111-1IInactivated by FDA2026-08-10

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 · 30 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 packagepackage50090-3111-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3111-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3111-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3111-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3111-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3111-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3111-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3111-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3111-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3111-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3111-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3111-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3111-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3111-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3111-11332a3947898…d4bfe170f9cd…

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
A065229-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25
A065229-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065229-001AB
A065229-002AB

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 UTC2026-02A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065229-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065229-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065229-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065229-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065229-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065229-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065229-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065229-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065229-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065229-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065229-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065229-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065229-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065229-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065229-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065229-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065229-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065229-002AB1782e0a99824c…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3111-1Cephalexin12 in 1 BOTTLECAPSULE123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3111-1EA - Each50090-311118db7b15-e5ab-43a4-af17-858450c27afd12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3111CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20200121_86fe2a70-3e02-4d43-8d96-d47d4895388a.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINREMEDYREPACK INC.b3bb8222-161e-4d9c-8e08-7e22ad65bf722026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINREMEDYREPACK INC.8499aa5a-49b1-4555-bd27-6177d92b261d2026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINCoupler LLC508a3401-df0b-0555-e063-6294a90a155a2026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINSportpharm LLC3d5a2665-65da-4b10-9e23-39fc88145da12026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc.13444dc7-7da1-4181-a9ac-d95d4a235e6d2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINLupin Pharmaceuticals, Inc.1d3e6d33-5dc2-498e-8efa-e3c4fca15dff2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINADVANCED RX PHARMACY OF TENNESSEE, LLCaf4abf8b-22cc-da58-e053-2a95a90aa7662024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.a33280d4-7caf-f74b-e053-2a95a90a90c32024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc945552cb-90e4-41fb-afe2-8ee8785e94da2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc.20f8cc57-231c-4d36-a209-ff9e5735d65c2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.728c5212-dbd8-8df5-e053-2a91aa0a95792024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINADVANCED RX PHARMACY OF TENNESSEE, LLCaf10128f-021a-14b7-e053-2a95a90a43652024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc.6032b68f-16d8-41b6-bd2c-86d5406a757a2022-09-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINProficient Rx LPdec3a1ef-1e85-4236-804b-e7a343d3a58f2022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN86fe2a70-3e02-4d43-8d96-d47d4895388a3
309114cephalexin 500 MG Oral CapsuleSCD86fe2a70-3e02-4d43-8d96-d47d4895388a3
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY86fe2a70-3e02-4d43-8d96-d47d4895388a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3111-15009031110112 CAPSULE in 1 BOTTLE (50090-3111-1) 12 capsule2017-08-010000-00-00NoNoCurrent