Cephalexin

Product NDC
68071-3538
11-digit product format
680713538
Labeler code
68071
Product ID
68071-3538_39731b80-e276-057e-e063-6394a90a4142
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065253
Marketing category
ANDA
Marketing start
2005-11-16
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OBN7UDS42YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309114Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0aad51b4-86d5-e312-e063-6394a90a250dAvailable on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3538-3Cephalexin30 in 1 BOTTLECAPSULE305
68071-3538-4Cephalexin4 in 1 BOTTLECAPSULE45
68071-3538-6Cephalexin6 in 1 BOTTLECAPSULE65
68071-3538-8Cephalexin8 in 1 BOTTLECAPSULE85
68071-3538-9Cephalexin9 in 1 BOTTLECAPSULE95

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3538CEPHALEXIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, 5 package rows20240820_0aad51b4-86d5-e312-e063-6394a90a250d.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
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
CephalexinCEPHALEXINREMEDYREPACK INC.2506895d-f3e0-4be9-95cb-7a6fd44de46d2026-04-03Warnings, 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
ndc (product): 68071-3538
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
309114cephalexin 500 MG Oral CapsulePSN0aad51b4-86d5-e312-e063-6394a90a250d5
309114cephalexin 500 MG Oral CapsuleSCD0aad51b4-86d5-e312-e063-6394a90a250d5
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY0aad51b4-86d5-e312-e063-6394a90a250d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3538-36807135380330 CAPSULE in 1 BOTTLE (68071-3538-3) 30 capsule2024-01-15NoNoCurrent
68071-3538-4680713538044 CAPSULE in 1 BOTTLE (68071-3538-4) 4 capsule2024-01-15NoNoCurrent
68071-3538-6680713538066 CAPSULE in 1 BOTTLE (68071-3538-6) 6 capsule2023-11-21NoNoCurrent
68071-3538-8680713538088 CAPSULE in 1 BOTTLE (68071-3538-8) 8 capsule2023-11-21NoNoCurrent
68071-3538-9680713538099 CAPSULE in 1 BOTTLE (68071-3538-9) 9 capsule2025-07-08NoNoCurrent