Cephalexin

Product NDC
63629-9204
11-digit product format
636299204
Labeler code
63629
Product ID
63629-9204_b7e7ec11-dee5-4ed2-ad3d-be967d311e26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210221
Marketing category
ANDA
Marketing start
2019-03-28
Substance
CEPHALEXIN
Active strength
125 mg/5mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210221-001CEPHALEXINCEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26
A210221-002CEPHALEXINCEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A210221-001AB
A210221-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210221-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210221-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2019-03-26bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210221-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210221-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210221-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210221-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210221-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210221-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210221-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210221-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210221-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210221-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210221-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210221-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210221-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210221-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210221-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210221-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210221-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210221-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210221-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210221-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210221-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210221-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210221-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210221-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210221-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210221-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210221-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210221-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210221-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210221-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210221-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210221-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210221-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210221-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210221-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210221-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210221-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210221-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210221-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210221-002AB1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN125 mg/5mL

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
309110Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4ced8c7-a276-4a44-a60c-f8d1689a2bdfAvailable 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
63629-9204-1Cephalexin100 mL in 1 BOTTLEFOR SUSPENSION100110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9204-1ML - Milliliter63629-9204dfa82e73-e4ca-41c3-b80a-f579b30dd3ae12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9204CEPHALEXIN FOR SUSPENSION [BRYANT RANCH PREPACK]110Current NDC, Legacy NDC, 1 package rows20240918_f4ced8c7-a276-4a44-a60c-f8d1689a2bdf.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 1 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINBryant Ranch Prepack06c2fb2e-0539-4f16-bac4-e15a575ca8022026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINPreferred Pharmaceuticlas Inc.fbf5fcdf-40fc-40e5-b784-308032fff0e52026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINPreferred Pharmaceuticals, Inc.6c7bfa58-2d38-4607-8c33-485ba4931c682026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.ee278959-d321-d356-e053-2995a90a32c22026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepackc7028200-b141-496b-89e9-491558d4c8792025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepack5f867aa3-ea64-4a14-a63b-979b8ff8d80c2025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINREMEDYREPACK INC.9fc5cfb0-7ba0-4669-b79c-270b6a9ff5732025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepack8d7f247a-3b42-4823-96fb-5f5c1bd94d492025-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepack1bfa8744-24ee-4c70-845c-c532b80844332025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepacka8f14231-5d43-46f7-ba1f-d6de8162d5e72024-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepacke186afb5-7531-45ea-b785-c230483a77472024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepackf1439d25-3d3d-4fe5-b6e7-d76e628929692024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINA-S Medication Solutions28fec572-e3b9-448c-8626-5c0920f38eeb2024-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepackdf6bb893-e3d7-4c8f-8cec-35b4d2fa33b32024-07-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepackf4ced8c7-a276-4a44-a60c-f8d1689a2bdf2024-07-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
ndc (product): 63629-9204
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.ada33464-b416-9ac6-e053-2a95a90af7872024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.90a76d24-e5a9-9000-e053-2a95a90ae8af2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINBryant Ranch Prepack92be9844-0775-4808-bdeb-dccb09647d912024-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINA-S Medication Solutions0edeb103-5e94-4f42-828f-c7336486c7842024-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221
CephalexinCEPHALEXINAscend Laboratories, LLCbb28751c-bd1b-4e7f-8271-a14c1b4314e32022-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210221
application number: ANDA210221

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309110cephalexin 125 MG in 5 mL Oral SuspensionPSNf4ced8c7-a276-4a44-a60c-f8d1689a2bdf110
309110cephalexin 25 MG/ML Oral SuspensionSCDf4ced8c7-a276-4a44-a60c-f8d1689a2bdf110
309110cefalexin 25 MG/ML Oral SuspensionSYf4ced8c7-a276-4a44-a60c-f8d1689a2bdf110
309110cephalexin 125 MG per 5 ML Oral SuspensionSYf4ced8c7-a276-4a44-a60c-f8d1689a2bdf110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9204-163629920401100 mL in 1 BOTTLE (63629-9204-1) 100 ml2019-03-280000-00-00NoNoCurrent