CEPHALEXIN

Product NDC
61919-522
Requested package NDC
61919-522-30
11-digit product format
619190522
Labeler code
61919
Product ID
61919-522_9c5b1895-9496-84b7-e053-2995a90a9940
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEPHALEXIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA062713
Marketing category
ANDA
Marketing start
2016-02-09
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-52261919-522-30DDiscontinued 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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
A062713-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15
A062713-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062713-001AB
A062713-002AB

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 06:07:402026-07A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062713-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1988-07-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062713-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1988-07-15bb7c543d1eb4…

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 06:07:402026-07A062713-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A062713-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062713-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062713-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062713-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062713-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062713-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062713-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062713-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062713-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062713-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062713-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062713-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062713-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062713-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062713-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062713-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062713-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062713-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062713-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062713-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062713-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062713-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062713-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062713-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062713-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062713-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062713-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062713-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062713-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062713-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062713-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062713-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062713-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062713-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062713-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062713-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062713-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062713-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062713-002AB1bb7c543d1eb4…

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
61919-522-30CEPHALEXIN1 in 1 BOTTLECAPSULE14
61919-522-20CEPHALEXIN20 in 1 BOTTLECAPSULE202
61919-522-40CEPHALEXIN40 in 1 BOTTLECAPSULE402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-522-20EA - Each61919-5223caf1806-9836-4921-ad60-4002ea43336212016-06-14
61919-522-30EA - Each61919-522aa36fad5-8804-482a-ae84-c004c42d502212019-04-11
61919-522-40EA - Each61919-522edc9f5ee-7efa-44b2-8063-1f534aca338d12016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cephalexinACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [DIRECTRX]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [DIRECTRX]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKCEPHALEXIN CAPSULE [DIRECTRX]2
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [DIRECTRX]2
gelatinINACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [DIRECTRX]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [DIRECTRX]2
talcINACTIVE INGREDIENT7SEV7J4R1UCEPHALEXIN CAPSULE [DIRECTRX]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [DIRECTRX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-522CEPHALEXIN CAPSULE [DIRECT RX]3Legacy NDC, 1 package rows20200129_2d12e6a9-f7dd-25ed-e054-00144ff8d46c.zip
61919-522CEPHALEXIN CAPSULE [DIRECTRX]2Legacy NDC, 2 package rows20151110_2081f146-534f-4bc6-ab56-448bf9a9a81a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINAvKARE03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062713
application number: ANDA062713
CEPHALEXINCEPHALEXINDIRECT RX2d12e6a9-f7dd-25ed-e054-00144ff8d46c2022-09-29Warnings, Adverse reactionsExact identifier
ndc (package): 61919-522-30
ndc (product): 61919-522
ndc11 (package): 61919052230

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSN2d12e6a9-f7dd-25ed-e054-00144ff8d46c4
309114cephalexin 500 MG Oral CapsuleSCD2d12e6a9-f7dd-25ed-e054-00144ff8d46c4
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY2d12e6a9-f7dd-25ed-e054-00144ff8d46c4
309114cephalexin 500 MG Oral CapsulePSN2081f146-534f-4bc6-ab56-448bf9a9a81a2
309114cephalexin 500 MG Oral CapsuleSCD2081f146-534f-4bc6-ab56-448bf9a9a81a2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY2081f146-534f-4bc6-ab56-448bf9a9a81a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-522-30619190522301 CAPSULE in 1 BOTTLE (61919-522-30) 1 capsule2016-02-090000-00-00NoNoCurrent