FDA.reportPublic FDA data

CEPHALEXIN

Product NDC
61919-606
11-digit product format
619190606
Labeler code
61919
Product ID
61919-606_4d288574-ca75-070f-e063-6394a90ac210
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEPHALEXIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090836
Marketing category
ANDA
Marketing start
2019-08-14
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CEPHALEXIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309114

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
61919-606-202025-01-30C16284748780-12cef2736-90d5-d83d-e063-dadaa90ab31fCEPHALEXIN
61919-606-142023-01-30C16284748780-1f386c649-dc1b-0266-e053-dadaa90a7c1aCEPHALEXIN
61919-606-282023-01-30C16284748780-1f386c649-f9ae-0266-e053-dadaa90a7c1aCEPHALEXIN
61919-606-302023-01-30C16284748780-1f386c64a-4604-0266-e053-dadaa90a7c1aCEPHALEXIN
61919-606-402023-01-30C16284748780-1f386c649-b92f-0266-e053-dadaa90a7c1aCEPHALEXIN
61919-606-562023-01-30C16284748780-1d6a99b39-a0d7-a426-e053-dadaa90af4c2CEPHALEXIN 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-606-10CEPHALEXIN10 in 1 BOTTLECAPSULE104
61919-606-56CEPHALEXIN56 in 1 BOTTLECAPSULE564
61919-606-60CEPHALEXIN60 in 1 BOTTLECAPSULE604
61919-606-20CEPHALEXIN20 in 1 BOTTLECAPSULE203
61919-606-30CEPHALEXIN30 in 1 BOTTLECAPSULE302
61919-606-14CEPHALEXIN14 in 1 BOTTLECAPSULE141
61919-606-28CEPHALEXIN28 in 1 BOTTLECAPSULE281
61919-606-40CEPHALEXIN40 in 1 BOTTLECAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-606-10EA - Each61919-60619cdedf3-66ac-4515-9153-4792e9a4d50d12026-04-20
61919-606-14EA - Each61919-606ee473118-e3ee-4365-8ad1-59a88b9fffc312019-09-05
61919-606-20EA - Each61919-606b2ae5ad0-1278-4816-8b7a-67504f2716de12019-09-05
61919-606-28EA - Each61919-606ce3e1698-218b-4187-9657-384754504c4412019-09-05
61919-606-30EA - Each61919-606ec503a30-325f-4ae2-a8d7-4dc677e0b46212019-09-05
61919-606-40EA - Each61919-606fc1b3c6d-8d4a-40b8-a78f-ada426be02a412019-09-05
61919-606-56EA - Each61919-6067569f67e-acc3-4f1e-a02a-23671bb3dcc812019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-606CEPHALEXIN CAPSULE [DIRECT RX]3Current NDC, Legacy NDC, 3 package rows20200129_2d12e6a9-f7dd-25ed-e054-00144ff8d46c.zip
61919-606CEPHALEXIN CAPSULE [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20230113_90148caf-4291-da8b-e053-2a95a90a9bd3.zip
61919-606CEPHALEXIN CAPSULE [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190815_90144ef8-07c4-7513-e053-2a95a90a9acf.zip
61919-606CEPHALEXIN CAPSULE [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190814_90056394-5a95-5f84-e053-2995a90af31a.zip
61919-606CEPHALEXIN CAPSULE [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190815_901428c4-bc25-3ed1-e053-2995a90a2d54.zip
61919-606CEPHALEXIN CAPSULE [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190814_90051655-77e9-6753-e053-2a95a90a462c.zip

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 CapsulePSN90148caf-4291-da8b-e053-2a95a90a9bd33
309114cephalexin 500 MG Oral CapsuleSCD90148caf-4291-da8b-e053-2a95a90a9bd33
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY90148caf-4291-da8b-e053-2a95a90a9bd33
309114cephalexin 500 MG Oral CapsulePSN90051655-77e9-6753-e053-2a95a90a462c2
309114cephalexin 500 MG Oral CapsuleSCD90051655-77e9-6753-e053-2a95a90a462c2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY90051655-77e9-6753-e053-2a95a90a462c2
309114cephalexin 500 MG Oral CapsulePSN90056394-5a95-5f84-e053-2995a90af31a1
309114cephalexin 500 MG Oral CapsulePSN901428c4-bc25-3ed1-e053-2995a90a2d541
309114cephalexin 500 MG Oral CapsulePSN90144ef8-07c4-7513-e053-2a95a90a9acf1
309114cephalexin 500 MG Oral CapsuleSCD90056394-5a95-5f84-e053-2995a90af31a1
309114cephalexin 500 MG Oral CapsuleSCD901428c4-bc25-3ed1-e053-2995a90a2d541
309114cephalexin 500 MG Oral CapsuleSCD90144ef8-07c4-7513-e053-2a95a90a9acf1
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY90056394-5a95-5f84-e053-2995a90af31a1
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY901428c4-bc25-3ed1-e053-2995a90a2d541
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY90144ef8-07c4-7513-e053-2a95a90a9acf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-606-106191906061010 CAPSULE in 1 BOTTLE (61919-606-10) 10 capsule2019-04-03NoNoHistorical
61919-606-146191906061414 CAPSULE in 1 BOTTLE (61919-606-14) 14 capsule2019-08-140000-00-00NoNoCurrent
61919-606-206191906062020 CAPSULE in 1 BOTTLE (61919-606-20) 20 capsule2019-08-140000-00-00NoNoCurrent
61919-606-286191906062828 CAPSULE in 1 BOTTLE (61919-606-28) 28 capsule2019-08-140000-00-00NoNoCurrent
61919-606-306191906063030 CAPSULE in 1 BOTTLE (61919-606-30) 30 capsule2019-08-130000-00-00NoNoCurrent
61919-606-406191906064040 CAPSULE in 1 BOTTLE (61919-606-40) 40 capsule2019-08-130000-00-00NoNoCurrent
61919-606-566191906065656 CAPSULE in 1 BOTTLE (61919-606-56) 56 capsule2019-04-030000-00-00NoNoCurrent
61919-606-606191906066060 CAPSULE in 1 BOTTLE (61919-606-60) 60 capsule2019-04-03NoNoHistorical