Cephalexin

Product NDC
55700-841
11-digit product format
557000841
Labeler code
55700
Product ID
55700-841_32f2d3d9-43ec-40b4-b837-13ba0ecc5645
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA210221
Marketing category
ANDA
Marketing start
2020-02-07
Marketing end
2021-10-31
Substance
CEPHALEXIN
Active strength
250 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-841DDiscontinued by firm2026-08-17
excluded packagepackage55700-84155700-841-00DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-841-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-841-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-841-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-841-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-841-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-841-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-841-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-841-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-841-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-841-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-841-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-841-00557ba5c1ecfa…9c80585c8c6e…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-841-00ML - Milliliter55700-841806663d9-f795-4902-8cac-f7dc4eb46b4212020-03-10

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-841-0055700084100100 mL in 1 BOTTLE (55700-841-00) 100 ml2020-02-070000-00-00NoNoCurrent