Cephalexin

Product NDC
66336-055
11-digit product format
663360055
Labeler code
66336
Product ID
66336-055_72c74c12-f8d9-47e4-968c-95591f7766d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA065253
Marketing category
ANDA
Marketing start
2005-11-16
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66336-055IInactivated by FDA2026-08-11
excluded packagepackage66336-05566336-055-00IInactivated by FDA2026-08-11

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 · 44 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 packagepackage66336-055-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-055-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-055-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-055-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-055-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-055-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-055-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-055-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-055-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-055-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66336-055-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66336-055-00557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66336-055-008af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66336-055-00834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66336-055-001332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66336-055-00fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66336-055-0086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66336-055-00bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66336-055-008dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66336-055-00e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66336-055-009bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66336-055-00110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065253-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16
A065253-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16
A065253-003CEPHALEXINCEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065253-001AB
A065253-002AB
A065253-003AB

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 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-003CEPHALEXINEQ 750MG BASECAPSULE / ORALAB2023-12-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065253-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-168072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065253-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065253-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065253-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065253-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065253-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065253-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065253-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065253-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065253-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065253-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065253-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065253-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065253-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065253-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065253-001AB18072bd15b7f6…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66336-055-002019-11-13C16284748780-197449f38-cbc3-f6ea-e053-dbdaa90aa703Cephalexin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-055-00Cephalexin100 in 1 BOTTLECAPSULE1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [DISPENSING SOLUTIONS, INC.]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [DISPENSING SOLUTIONS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEPHALEXIN CAPSULE [DISPENSING SOLUTIONS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [DISPENSING SOLUTIONS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [DISPENSING SOLUTIONS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-055CEPHALEXIN CAPSULE [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20120926_2c9b951f-76f5-4f2d-89c3-1b09f9bb2002.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINREMEDYREPACK INC.2506895d-f3e0-4be9-95cb-7a6fd44de46d2026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.88426cb3-1c0c-439b-9f1a-aa169040c29f2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNorthwind Health Company, LLC1d0d50ba-8c2c-855c-e063-6394a90a5c7d2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack47b6bc70-e8cc-4837-a39a-6998ee4e37dc2026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack8a938dd0-fca6-4f22-9fb0-6325966030012026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.52d8a080-eafc-46fe-82d9-6b69c6a3a38a2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINChartwell RX, LLCd315cce8-9784-419e-818b-16d68d1dbd6e2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.0b3da88f-f513-cdf0-e063-6394a90a72052025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack2070b988-f7fb-4e35-91e3-1b7df5e5326c2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINAMELLA PHARMA, LLC602fae70-3b8a-4f09-8db1-41fef4a2ecd72025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINREMEDYREPACK INC.c0ca008e-0e28-412e-a58f-70f63817713b2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepackf3b46058-3e53-413b-b9c9-7d49e50f861e2025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack88a744d8-a95e-4c63-8b25-52f5039b6ba12025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.0aad51b4-86d5-e312-e063-6394a90a250d2025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack50f0187b-09e7-4c11-970f-91cd1877fde12025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepack905b3270-abbd-4d5c-b313-3d20eb4b4c572025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINBryant Ranch Prepackf2e73727-2ab6-4418-9677-19ea1d140bbd2025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINCoupler, LLC30b7071e-cef1-bd41-e063-6394a90ad48e2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINNuCare Pharmaceuticals, Inc.28da5822-fb0b-1306-e063-6394a90a6e4c2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253
CephalexinCEPHALEXINA-S Medication Solutions02b5cd6f-3df8-43c1-879d-217fcf55231a2025-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065253
application number: ANDA065253

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN2c9b951f-76f5-4f2d-89c3-1b09f9bb20022
309114cephalexin 500 MG Oral CapsuleSCD2c9b951f-76f5-4f2d-89c3-1b09f9bb20022
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY2c9b951f-76f5-4f2d-89c3-1b09f9bb20022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-055-0066336005500100 in 1 BOTTLEHistorical