Cephalexin

Product NDC
54348-555
Requested package NDC
54348-555-20
11-digit product format
543480555
Labeler code
54348
Product ID
54348-555_ea931c26-4e14-37a4-e053-2995a90a11d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEPHALEXIN
Dosage form
CAPSULE
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA090836
Marketing category
ANDA
Marketing start
2019-07-12
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
2023-12-31
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 packagepackage54348-55554348-555-20DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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…

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-555-20543480555201 BOTTLE in 1 BOX (54348-555-20) > 20 CAPSULE in 1 BOTTLE1 bottle2019-07-120000-00-00NoNoCurrent