Cephalexin

Product NDC
10544-020
11-digit product format
105440020
Labeler code
10544
Product ID
10544-020_9fc0b42f-ecb7-4070-a18c-e57d5a53778a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA062702
Marketing category
ANDA
Marketing start
2010-09-28
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10544-020IInactivated by FDA2026-08-17
excluded packagepackage10544-02010544-020-10IInactivated by FDA2026-08-17
excluded packagepackage10544-02010544-020-14IInactivated by FDA2026-08-17
excluded packagepackage10544-02010544-020-20IInactivated by FDA2026-08-17
excluded packagepackage10544-02010544-020-28IInactivated by FDA2026-08-17
excluded packagepackage10544-02010544-020-30IInactivated by FDA2026-08-17
excluded packagepackage10544-02010544-020-40IInactivated by FDA2026-08-17

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 3 · 154 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 packagepackage10544-020-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-020-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-020-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-020-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-020-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-020-28d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-020-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-020-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-020-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-020-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-020-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-020-28f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-020-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-020-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-020-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-020-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-020-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-020-282ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-020-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-020-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-020-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-020-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-020-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-020-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-020-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-020-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-020-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-020-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-020-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-020-28cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-020-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-020-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-020-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-020-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-020-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-020-28cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-020-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-020-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-020-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-020-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-020-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-020-28302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-020-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-020-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-020-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-020-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-020-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-020-28ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-020-140efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-020-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-020-300efc9e666f02…f202fb6c5f17…

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
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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13caaa826d4ba7…
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…

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 06:07:402026-07A062702-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A062702-002AB1caaa826d4ba7…
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…

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
10544-020-10Cephalexin10 in 1 BOTTLECAPSULE101
10544-020-14Cephalexin14 in 1 BOTTLECAPSULE141
10544-020-20Cephalexin20 in 1 BOTTLECAPSULE201
10544-020-28Cephalexin28 in 1 BOTTLECAPSULE281
10544-020-30Cephalexin30 in 1 BOTTLECAPSULE301
10544-020-40Cephalexin40 in 1 BOTTLECAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-020-10EA - Each10544-020a6d9ba0a-c953-4e62-8288-886770403b1512015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
CEPHALEXINACTIVE MOIETYOBN7UDS42YCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-020CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 6 package rows20101007_12b6bac5-00a3-437b-a172-d4e09c273c8c.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 CapsulePSN12b6bac5-00a3-437b-a172-d4e09c273c8c1
309114cephalexin 500 MG Oral CapsuleSCD12b6bac5-00a3-437b-a172-d4e09c273c8c1
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY12b6bac5-00a3-437b-a172-d4e09c273c8c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-020-101054400201010 in 1 BOTTLEHistorical
10544-020-141054400201414 in 1 BOTTLEHistorical
10544-020-201054400202020 in 1 BOTTLEHistorical
10544-020-281054400202828 in 1 BOTTLEHistorical
10544-020-301054400203030 in 1 BOTTLEHistorical
10544-020-401054400204040 in 1 BOTTLEHistorical