Cephalexin

Product NDC
85766-005
11-digit product format
857660005
Labeler code
85766
Product ID
85766-005_49ee93c6-9968-038d-e063-6394a90affea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA090836
Marketing category
ANDA
Marketing start
2019-08-19
Substance
CEPHALEXIN
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090836-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB2010-12-20
A090836-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB2010-12-20
A090836-003CEPHALEXINCEPHALEXINEQ 333MG BASECAPSULE / ORAL2013-03-29
A090836-004CEPHALEXINCEPHALEXINEQ 750MG BASECAPSULE / ORALABRS2013-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090836-001AB
A090836-002AB
A090836-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090836-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2010-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090836-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2010-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090836-003CEPHALEXINEQ 333MG BASECAPSULE / ORAL2013-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090836-004CEPHALEXINEQ 750MG BASECAPSULE / ORALABRS2013-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090836-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2010-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090836-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2010-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090836-003CEPHALEXINEQ 333MG BASECAPSULE / ORAL2013-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090836-004CEPHALEXINEQ 750MG BASECAPSULE / ORALABRS2013-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090836-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2010-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090836-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2010-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090836-003CEPHALEXINEQ 333MG BASECAPSULE / ORAL2013-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090836-004CEPHALEXINEQ 750MG BASECAPSULE / ORALABRS2013-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090836-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2010-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090836-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2010-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090836-003CEPHALEXINEQ 333MG BASECAPSULE / ORAL2013-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090836-004CEPHALEXINEQ 750MG BASECAPSULE / ORALABRS2013-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090836-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2010-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090836-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2010-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090836-003CEPHALEXINEQ 333MG BASECAPSULE / ORAL2013-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090836-004CEPHALEXINEQ 750MG BASECAPSULE / ORALABRS2013-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090836-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2010-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090836-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2010-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090836-003CEPHALEXINEQ 333MG BASECAPSULE / ORAL2013-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090836-004CEPHALEXINEQ 750MG BASECAPSULE / ORALABRS2013-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090836-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2010-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090836-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2010-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090836-003CEPHALEXINEQ 333MG BASECAPSULE / ORAL2013-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090836-004CEPHALEXINEQ 750MG BASECAPSULE / ORALABRS2013-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090836-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2010-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090836-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2010-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090836-003CEPHALEXINEQ 333MG BASECAPSULE / ORAL2013-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090836-004CEPHALEXINEQ 750MG BASECAPSULE / ORALABRS2013-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090836-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2010-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090836-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2010-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090836-003CEPHALEXINEQ 333MG BASECAPSULE / ORAL2013-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090836-004CEPHALEXINEQ 750MG BASECAPSULE / ORALABRS2013-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090836-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2010-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A090836-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2010-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A090836-003CEPHALEXINEQ 333MG BASECAPSULE / ORAL2013-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A090836-004CEPHALEXINEQ 750MG BASECAPSULE / ORALABRS2013-03-29d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090836-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090836-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090836-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090836-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090836-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090836-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090836-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090836-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090836-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090836-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090836-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090836-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090836-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090836-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090836-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090836-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090836-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090836-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090836-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090836-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090836-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090836-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090836-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090836-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090836-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090836-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090836-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090836-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090836-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090836-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090836-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090836-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090836-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090836-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090836-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090836-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090836-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090836-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090836-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090836-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN250 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
309112Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
75820198-5efe-4ba0-ad50-e88d22fe075eAvailable 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
85766-005-28Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE283
85766-005-30Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE303
85766-005-40Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE403

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 4 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINREMEDYREPACK INC.a6b5edf2-1ef8-46b7-977a-8c303900f3f02026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINBryant Ranch Prepack0384c418-b4d4-4c06-9ed9-13e864b1980b2026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINBryant Ranch Prepackd6954168-9c7f-4a6c-9262-2e6bed5c9f242026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINBryant Ranch Prepack7508351d-69fe-457c-b450-9a2343be25872026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINBryant Ranch Prepack980b9dd9-cb61-4c4f-81ac-85ee5a7c24972026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINBryant Ranch Prepack759c3856-8d3a-4036-926c-8508b573c7362026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINBryant Ranch Prepack5b9b212a-3a3e-4637-b23c-6d66d8cf11712026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINBryant Ranch Prepack11cfefee-d75e-430c-8817-02dc57de0e882026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINBryant Ranch Prepack43ca66ae-2ada-412d-bc5d-f53602f535a52026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINBryant Ranch Prepackcf1c5d03-eddc-463a-84ad-4d59362c2cf82026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINHAWAII REPACK, INC.d54abc0a-3c8f-4f02-bd55-406f0c5b925a2026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINNorthwind Health Company, LLC4ecf9314-76e2-c270-e063-6294a90ad8db2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.e54df878-c235-4aa3-af33-fe5287c731382026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINAscend Laboratories, LLC4fec8daf-6e09-4153-926f-64709dbdd26c2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINProficient Rx LP7059a0b2-dd57-4fc1-ac3d-6aead35a4b082026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINREMEDYREPACK INC.c600a2c0-42ab-4be8-b9b1-59ba39494b3f2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CEPHALEXINCEPHALEXINDirect_Rx90051655-77e9-6753-e053-2a95a90a462c2026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINSportpharm LLCda97ca40-3b22-432b-a3e9-0902dbef06a92026-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.a24a3c7c-c0f8-4107-ab30-751bea743d2d2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CEPHALEXINCEPHALEXINDirect_Rx90148caf-4291-da8b-e053-2a95a90a9bd32026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN75820198-5efe-4ba0-ad50-e88d22fe075e3
309112cephalexin 250 MG Oral CapsuleSCD75820198-5efe-4ba0-ad50-e88d22fe075e3
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY75820198-5efe-4ba0-ad50-e88d22fe075e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-005-288576600052828 CAPSULE in 1 BOTTLE, PLASTIC (85766-005-28) 28 capsule2025-06-18NoNoCurrent
85766-005-308576600053030 CAPSULE in 1 BOTTLE, PLASTIC (85766-005-30) 30 capsule2025-06-18NoNoCurrent
85766-005-408576600054040 CAPSULE in 1 BOTTLE, PLASTIC (85766-005-40) 40 capsule2025-06-18NoNoCurrent