CEPHALEXIN

Product NDC
61919-051
11-digit product format
619190051
Labeler code
61919
Product ID
61919-051_40b7d8a4-e83b-274a-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEPHALEXIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA062791
Marketing category
ANDA
Marketing start
2014-01-01
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-051UExcluded because listing certification expired2026-08-07
excluded packagepackage61919-05161919-051-20UExcluded because listing certification expired2026-08-07
excluded packagepackage61919-05161919-051-30UExcluded because listing certification expired2026-08-07
excluded packagepackage61919-05161919-051-40UExcluded because listing certification expired2026-08-07

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 2 · 88 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 packagepackage61919-051-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-051-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-051-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-051-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-051-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-051-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-051-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-051-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-051-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-051-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-051-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-051-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-051-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-051-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-051-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-051-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-051-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-051-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-051-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-051-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-051-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-051-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-051-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-051-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-051-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-051-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-051-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-051-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-051-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-051-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-051-40367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-051-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-051-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-051-40557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-051-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-051-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-051-408af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-051-208af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-051-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-051-40834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-051-20834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-051-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-051-401332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-051-201332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-051-301332a3947898…d4bfe170f9cd…

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
A062791-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-11
A062791-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-11

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 UTC2026-02A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062791-001CEPHALEXINEQ 250MG BASECAPSULE / ORAL1987-06-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A062791-002CEPHALEXINEQ 500MG BASECAPSULE / ORAL1987-06-11782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A062791-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A062791-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062791-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A062791-002AB1ea99ee380514…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-051-20CEPHALEXIN20 in 1 BOTTLECAPSULE204
61919-051-30CEPHALEXIN30 in 1 BOTTLECAPSULE304
61919-051-40CEPHALEXIN40 in 1 BOTTLECAPSULE404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-051-20EA - Each61919-051da2bfd9d-2350-46a6-a44d-5018dc83e25412015-04-03
61919-051-30EA - Each61919-051a5906da6-3982-4ff1-bcd0-6fb029693ba712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [DIRECT RX]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [DIRECT RX]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [DIRECT RX]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [DIRECT RX]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [DIRECT RX]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEPHALEXIN CAPSULE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-051CEPHALEXIN CAPSULE [DIRECT RX]4Legacy NDC, 3 package rows20161114_d6b3940f-a296-44a4-adf2-9e396909add2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNd6b3940f-a296-44a4-adf2-9e396909add24
309114cephalexin 500 MG Oral CapsuleSCDd6b3940f-a296-44a4-adf2-9e396909add24
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYd6b3940f-a296-44a4-adf2-9e396909add24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-051-206191900512020 in 1 BOTTLEHistorical
61919-051-306191900513030 in 1 BOTTLEHistorical
61919-051-406191900514040 in 1 BOTTLEHistorical