Theophylline

Product NDC
68151-4210
11-digit product format
681514210
Labeler code
68151
Product ID
68151-4210_ff1a49fb-b5fd-4f50-8f9f-ef2718c53478
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA040560
Marketing category
ANDA
Marketing start
2007-06-01
Marketing end
0000-00-00
Substance
THEOPHYLLINE ANHYDROUS
Active strength
600 mg/1
Pharmacologic classes
Methylxanthine [EPC],Xanthines [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1d07c79-5983-427d-b6f5-df0550dcc598Product name420250325
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2Product name120170302

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-4210-02020-01-31C16284748780-19d75b9d0-fcee-f424-e053-dadaa90a57ceTheophylline (Anhydrous) Extended-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4210-0Theophylline(Anhydrous)1 in 1 PACKAGETABLET, EXTENDED RELEASE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
THEOPHYLLINE ANHYDROUSACTIVE INGREDIENT0I55128JYKTHEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
THEOPHYLLINE ANHYDROUSACTIVE MOIETY0I55128JYKTHEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4210THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_c88d2f3e-3478-4ed4-b4da-44dece7818e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348472theophylline 600 MG Extended Release Oral TabletPSNc88d2f3e-3478-4ed4-b4da-44dece7818e93
348472theophylline 600 MG Extended Release Oral TabletSCDc88d2f3e-3478-4ed4-b4da-44dece7818e93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4210-0681514210001 in 1 PACKAGEHistorical