FDA.reportPublic FDA data

SUPRAX

Product NDC
70934-079
11-digit product format
709340079
Labeler code
70934
Product ID
70934-079_9abb3209-588b-fdba-e053-2a95a90ae15b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefixime
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
NDA203195
Marketing category
NDA
Marketing start
2018-02-09
Marketing end
0000-00-00
Substance
CEFIXIME
Active strength
400 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b2162c7-9766-84dc-4509-6d61a89e78a5Product name520210729
7953affb-a49b-11df-6839-b5f62ce45d92Product name620210729

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-079-012021-01-29C16284748780-1ba0f9c33-3579-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SUPRAX® safely and effectively. See full prescribing information for SUPRAX®. SUPRAX® (cefixime) tablets, for oral use SUPRAX® (cefixime) capsules, for oral use SUPRAX® (cefixime) chewable tablets, for oral use SUPRAX® (cefixime) for oral suspension Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-079-01SUPRAX1 in 1 BOTTLE, PLASTICCAPSULE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-079-01EA - Each70934-079ed94cc8f-267a-4595-82fa-951f62797bd012018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-079SUPRAX (CEFIXIME) CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 1 package rows20191228_655a59ba-08e9-51d4-e053-2991aa0aef34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
409823cefixime 400 MG Oral CapsulePSN655a59ba-08e9-51d4-e053-2991aa0aef342
1372999Suprax 400 MG Oral CapsulePSN655a59ba-08e9-51d4-e053-2991aa0aef342
1372999cefixime 400 MG Oral Capsule [Suprax]SBD655a59ba-08e9-51d4-e053-2991aa0aef342
409823cefixime 400 MG Oral CapsuleSCD655a59ba-08e9-51d4-e053-2991aa0aef342
1372999Suprax 400 MG Oral CapsuleSY655a59ba-08e9-51d4-e053-2991aa0aef342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70934-079-01709340079011 in 1 BOTTLE, PLASTICHistorical