Cephalexin

Product NDC
53808-0222
11-digit product format
538080222
Labeler code
53808
Product ID
53808-0222_ccd16e47-b47c-48e5-8281-f679ae506ddc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEPHALEXIN
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA062702
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
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 productproduct53808-0222IInactivated by FDA2026-08-10
excluded packagepackage53808-022253808-0222-1IInactivated by FDA2026-08-10

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 packagepackage53808-0222-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0222-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0222-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0222-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0222-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0222-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0222-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0222-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0222-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0222-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0222-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0222-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0222-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0222-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0222-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0222-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0222-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0222-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0222-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0222-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0222-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53808-0222-1110d247fa046…a55b01930146…

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

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
A062702-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13
A062702-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062702-001AB
A062702-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062702-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062702-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062702-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062702-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062702-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062702-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062702-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062702-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062702-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062702-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062702-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062702-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062702-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062702-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062702-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062702-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062702-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062702-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062702-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062702-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062702-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062702-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062702-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062702-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062702-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062702-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062702-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062702-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062702-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062702-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062702-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062702-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062702-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062702-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062702-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062702-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062702-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062702-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062702-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062702-002AB1782e0a99824c…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0222-1Cephalexin30 in 1 BLISTER PACKCAPSULE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CEPHALEXINACTIVE MOIETYOBN7UDS42YCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0222CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100806_704ed0b7-4ad3-4bb6-beac-221d20238216.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINREMEDYREPACK INC.b73593ce-0b1f-4371-bae1-140742de3b422026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINUnit Dose Solutions, Inc.53704ffd-b4f6-8b61-e063-6394a90a01f92026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.ad676021-44f3-4a97-a3dc-28a62fe982bb2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.3fed2817-fc0d-43cd-9f02-948fbc76672c2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINAVKARE74f83298-57f7-4166-8dd8-db3e556a68d82025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINQPharma Ince8b3ece4-cf73-416c-8767-68f425df35f82025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINQPharma Inc4e9a8ed3-c490-4a0e-bb29-5eea506f893b2025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.6ce11859-aa21-4b3f-bd59-3cd26deca82b2025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINA-S Medication Solutionsbff3912c-c39c-40c0-98d2-27c3d506c24d2025-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.ade02343-3e4b-b1f1-e053-2995a90ac5fe2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINA-S Medication Solutionsfc426d0d-9774-4189-8d83-89aa85d926bb2024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINA-S Medication Solutions5b7666f3-4014-45ce-8387-3298d9fe6d252024-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINBryant Ranch Prepack18518154-30ba-48a4-852a-3a77230300712023-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINProficient Rx LPada7b8a5-98f4-454c-b38f-92192d4db33f2021-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINTeva Pharmaceuticals USA, Inc.19307ff0-71de-477b-965d-ea243e5ede3a2020-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN704ed0b7-4ad3-4bb6-beac-221d202382161
309114cephalexin 500 MG Oral CapsuleSCD704ed0b7-4ad3-4bb6-beac-221d202382161
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY704ed0b7-4ad3-4bb6-beac-221d202382161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0222-15380802220130 in 1 BLISTER PACKHistorical