Cephalexin

Product NDC
50090-0070
Requested package NDC
50090-0070-2
11-digit product format
500900070
Labeler code
50090
Product ID
50090-0070_07affd1a-d231-4c13-97fe-81dd11b3ee8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065253
Marketing category
ANDA
Marketing start
2005-11-16
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
250 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-007050090-0070-2DDiscontinued by firm2026-08-11

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065253-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16
A065253-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16
A065253-003CEPHALEXINCEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065253-001AB
A065253-002AB
A065253-003AB

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 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-168072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065253-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065253-001AB18072bd15b7f6…

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-0070-22024-10-24These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
50090-0070-32024-10-24These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
50090-0070-42024-10-24These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
50090-0070-52024-10-24These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
50090-0070-82024-10-24These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
50090-0070-22023-01-30These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
50090-0070-32023-01-30These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
50090-0070-42023-01-30These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
50090-0070-52023-01-30These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
50090-0070-82023-01-30These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0070-2Cephalexin20 in 1 BOTTLECAPSULE2014
50090-0070-3Cephalexin28 in 1 BOTTLECAPSULE2814
50090-0070-4Cephalexin40 in 1 BOTTLECAPSULE4014
50090-0070-5Cephalexin30 in 1 BOTTLECAPSULE3014
50090-0070-8Cephalexin4 in 1 BOTTLECAPSULE414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0070-2EA - Each50090-0070bf8230ca-ec47-4894-9e47-73c69e854da312018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0070CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS]14Legacy NDC, 5 package rows20241027_99ef59d5-bc44-4727-86fe-dc81357207c3.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINREMEDYREPACK INC.2506895d-f3e0-4be9-95cb-7a6fd44de46d2026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.88426cb3-1c0c-439b-9f1a-aa169040c29f2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNorthwind Health Company, LLC1d0d50ba-8c2c-855c-e063-6394a90a5c7d2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack47b6bc70-e8cc-4837-a39a-6998ee4e37dc2026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack8a938dd0-fca6-4f22-9fb0-6325966030012026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.52d8a080-eafc-46fe-82d9-6b69c6a3a38a2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINChartwell RX, LLCd315cce8-9784-419e-818b-16d68d1dbd6e2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.0b3da88f-f513-cdf0-e063-6394a90a72052025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack2070b988-f7fb-4e35-91e3-1b7df5e5326c2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINAMELLA PHARMA, LLC602fae70-3b8a-4f09-8db1-41fef4a2ecd72025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINREMEDYREPACK INC.c0ca008e-0e28-412e-a58f-70f63817713b2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepackf3b46058-3e53-413b-b9c9-7d49e50f861e2025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack88a744d8-a95e-4c63-8b25-52f5039b6ba12025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.0aad51b4-86d5-e312-e063-6394a90a250d2025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack50f0187b-09e7-4c11-970f-91cd1877fde12025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack905b3270-abbd-4d5c-b313-3d20eb4b4c572025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepackf2e73727-2ab6-4418-9677-19ea1d140bbd2025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINCoupler, LLC30b7071e-cef1-bd41-e063-6394a90ad48e2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNuCare Pharmaceuticals, Inc.28da5822-fb0b-1306-e063-6394a90a6e4c2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINA-S Medication Solutions02b5cd6f-3df8-43c1-879d-217fcf55231a2025-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN99ef59d5-bc44-4727-86fe-dc81357207c314
309114cephalexin 500 MG Oral CapsulePSN99ef59d5-bc44-4727-86fe-dc81357207c314
309112cephalexin 250 MG Oral CapsuleSCD99ef59d5-bc44-4727-86fe-dc81357207c314
309114cephalexin 500 MG Oral CapsuleSCD99ef59d5-bc44-4727-86fe-dc81357207c314
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY99ef59d5-bc44-4727-86fe-dc81357207c314
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY99ef59d5-bc44-4727-86fe-dc81357207c314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0070-25009000700220 CAPSULE in 1 BOTTLE (50090-0070-2) 20 capsule2014-11-280000-00-00NoNoCurrent