cephalexin

Product NDC
68180-123
11-digit product format
681800123
Labeler code
68180
Product ID
68180-123_b456b5a9-f268-4ccf-8dde-ac001a2961a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065234
Marketing category
ANDA
Marketing start
2006-01-11
Marketing end
2020-01-01
Substance
CEPHALEXIN
Active strength
125 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68180-123DDiscontinued by firm2026-08-17
excluded packagepackage68180-12368180-123-01DDiscontinued by firm2026-08-17
excluded packagepackage68180-12368180-123-02DDiscontinued 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 · 36 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 packagepackage68180-123-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68180-123-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68180-123-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68180-123-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68180-123-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68180-123-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68180-123-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68180-123-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68180-123-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68180-123-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68180-123-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68180-123-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68180-123-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68180-123-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68180-123-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68180-123-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68180-123-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68180-123-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68180-123-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68180-123-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68180-123-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68180-123-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68180-123-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68180-123-02557ba5c1ecfa…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
A065234-001CEPHALEXINCEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17
A065234-002CEPHALEXINCEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065234-001AB
A065234-002AB

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 06:07:402026-07A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17caaa826d4ba7…
2026-08-18 06:07:402026-07A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065234-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065234-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2005-08-17bb7c543d1eb4…

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 06:07:402026-07A065234-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065234-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065234-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065234-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065234-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065234-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065234-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065234-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065234-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065234-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065234-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065234-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065234-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065234-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065234-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065234-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065234-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065234-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065234-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065234-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065234-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065234-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065234-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065234-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065234-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065234-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065234-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065234-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065234-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065234-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065234-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065234-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065234-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065234-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065234-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065234-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065234-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065234-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065234-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065234-002AB1bb7c543d1eb4…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dfa3f520-409c-432e-b6d3-9250d468c772Product name120250401
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-123-01cephalexin100 mL in 1 BOTTLEFOR SUSPENSION10013
68180-123-02cephalexin200 mL in 1 BOTTLEFOR SUSPENSION20013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-123-01ML - Milliliter68180-123dc37e527-d07a-4c3b-8749-d9f27940511512012-07-24
68180-123-02ML - Milliliter68180-1236d1eb0e2-a2f6-4d15-aa5d-e3d3203c3df612012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-123CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]10Legacy NDC, 2 package rows20240817_25ef498a-7a7e-4543-a544-b9d0e99f9cd9.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cephalexinCEPHALEXINLupin Pharmaceuticals, Inc.25ef498a-7a7e-4543-a544-b9d0e99f9cd92026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065234
application number: ANDA065234
ndc (product): 68180-123
cephalexinCEPHALEXINPreferred Pharmaceuticals Inc.553485f8-890d-4929-a6bb-905221cf411d2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065234
application number: ANDA065234
cephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.141bd050-5dfc-68fa-e063-6394a90a6d862024-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065234
application number: ANDA065234
cephalexinCEPHALEXINA-S Medication Solutionsd31da5be-c939-4aa0-adb8-b26a1396b2282024-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065234
application number: ANDA065234
cephalexinCEPHALEXINProficient Rx LP829244bd-93da-4a5a-a257-890cfec4c06d2023-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065234
application number: ANDA065234
cephalexinCEPHALEXINA-S Medication Solutions0a24b6e5-6f13-44b4-93f4-47c86945cad22023-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065234
application number: ANDA065234

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68180-123-0168180012301100 mL in 1 BOTTLE100 mlHistorical
68180-123-0268180012302200 mL in 1 BOTTLE200 mlHistorical