Cephalexin

Product NDC
0904-7337
11-digit product format
009047337
Labeler code
0904
Product ID
0904-7337_1c1fbad7-bef4-42a0-a8c9-b35168f5d533
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090836
Marketing category
ANDA
Marketing start
2023-11-06
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 42.

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090836-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2010-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A090836-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2010-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A090836-003CEPHALEXINEQ 333MG BASECAPSULE / ORAL2013-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A090836-004CEPHALEXINEQ 750MG BASECAPSULE / ORALABRS2013-03-29caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090836-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090836-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090836-004AB1caaa826d4ba7…
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…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309112Internal RxNorm lookup
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
1c1fbad7-bef4-42a0-a8c9-b35168f5d533Available 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
0904-7337-06Cephalexin50 in 1 CARTONCAPSULE501
0904-7337-06Cephalexin1 in 1 BLISTER PACKCAPSULE11
0904-7337-61Cephalexin1 in 1 BLISTER PACKCAPSULE11
0904-7337-61Cephalexin100 in 1 CARTONCAPSULE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7337-06EA - Each0904-733767b35870-f4fb-4a6b-b732-c1b1e116a0df12023-12-05
0904-7337-61EA - Each0904-7337b25f9a52-51a1-4966-b4dc-feb05a7c8a4712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7337CEPHALEXIN CAPSULE [MAJOR PHARMACEUTICALS]1Current NDC, 4 package rows20231110_1c1fbad7-bef4-42a0-a8c9-b35168f5d533.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 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.864d2046-b2c8-415c-814b-512bc4901c762026-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINREMEDYREPACK INC.c600a2c0-42ab-4be8-b9b1-59ba39494b3f2026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.af3e9919-3812-4917-bb6e-266a692ee4ab2026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.a24a3c7c-c0f8-4107-ab30-751bea743d2d2026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.3dc725a0-6e4b-45c6-9569-34ef654558452026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.e4e1ebcf-b43b-4dbe-9295-eeef67ba62722026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
CephalexinCEPHALEXINREMEDYREPACK INC.d3527c0a-94e4-46a2-be77-d936abcd19ec2026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090836
application number: ANDA090836
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309112cephalexin 250 MG Oral CapsulePSN1c1fbad7-bef4-42a0-a8c9-b35168f5d5331
309114cephalexin 500 MG Oral CapsulePSN1c1fbad7-bef4-42a0-a8c9-b35168f5d5331
309112cephalexin 250 MG Oral CapsuleSCD1c1fbad7-bef4-42a0-a8c9-b35168f5d5331
309114cephalexin 500 MG Oral CapsuleSCD1c1fbad7-bef4-42a0-a8c9-b35168f5d5331
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY1c1fbad7-bef4-42a0-a8c9-b35168f5d5331
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY1c1fbad7-bef4-42a0-a8c9-b35168f5d5331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7337-060090473370650 BLISTER PACK in 1 CARTON (0904-7337-06) / 1 CAPSULE in 1 BLISTER PACK50 blister pack2023-11-06NoNoCurrent
0904-7337-6100904733761100 BLISTER PACK in 1 CARTON (0904-7337-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2023-11-06NoNoCurrent