FDA.reportPublic FDA data

Cefadroxil

Product NDC
70934-081
11-digit product format
709340081
Labeler code
70934
Product ID
70934-081_b554b787-a7d4-0993-e053-2995a90ade1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA065392
Marketing category
ANDA
Marketing start
2018-02-14
Marketing end
0000-00-00
Substance
CEFADROXIL
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
560bed03-0257-a1db-0638-2c46fc35054cProduct name220170824
34f1b9ee-0673-df8c-ddae-36eaf4c48382Product name120140508
3793572a-4958-68b2-f923-8cf695ec1cc1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-081-142023-01-30C16284748780-1f386c649-c734-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg
70934-081-202023-01-30C16284748780-1f386c649-c734-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg
70934-081-912023-01-30C16284748780-1f386c649-c734-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg
70934-081-942023-01-30C16284748780-1f386c649-c734-0266-e053-dadaa90a7c1aCefadroxil Capsules USP 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-081-14Cefadroxil14 in 1 BOTTLE, PLASTICCAPSULE144
70934-081-20Cefadroxil20 in 1 BOTTLE, PLASTICCAPSULE204
70934-081-91Cefadroxil20 in 1 DOSE PACKCAPSULE204
70934-081-94Cefadroxil30 in 1 DOSE PACKCAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-081-91EA - Each70934-081b59b2f2c-16c2-41d8-85eb-58487ab7b4ca12018-11-06
70934-081-94EA - Each70934-081deb7f324-3b2b-4c79-aacf-354205f3f7d912018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-081CEFADROXIL CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]4Legacy NDC, 4 package rows20201204_691e3784-84bf-4e7f-e053-2991aa0a5a24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN691e3784-84bf-4e7f-e053-2991aa0a5a244
309049cefadroxil 500 MG Oral CapsuleSCD691e3784-84bf-4e7f-e053-2991aa0a5a244
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY691e3784-84bf-4e7f-e053-2991aa0a5a244

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-081-147093400811414 CAPSULE in 1 BOTTLE, PLASTIC (70934-081-14) 14 capsule2020-10-230000-00-00NoNoCurrent
70934-081-207093400812020 CAPSULE in 1 BOTTLE, PLASTIC (70934-081-20) 20 capsule2019-04-100000-00-00NoNoCurrent
70934-081-917093400819120 CAPSULE in 1 DOSE PACK (70934-081-91) 20 capsule2018-06-110000-00-00NoNoCurrent
70934-081-947093400819430 CAPSULE in 1 DOSE PACK (70934-081-94) 30 capsule2018-02-140000-00-00NoNoCurrent