Theophylline

Product NDC
68151-1393
11-digit product format
681511393
Labeler code
68151
Product ID
68151-1393_7fe01ca0-e1e8-4402-9e7e-60c263cbc610
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA090430
Marketing category
ANDA
Marketing start
2016-01-29
Marketing end
0000-00-00
Substance
THEOPHYLLINE ANHYDROUS
Active strength
300 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
68151-1393-12020-01-31C16284748780-19d75b9cf-ec39-f424-e053-dadaa90a57ceTheophylline Extended-Release Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-1393-1Theophylline1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-1393THEOPHYLLINE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20171228_6bc8923e-b7db-40a5-b22a-a975ca2bf1fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317769theophylline 300 MG Extended Release Oral TabletPSN6bc8923e-b7db-40a5-b22a-a975ca2bf1fd2
317769theophylline 300 MG Extended Release Oral TabletSCD6bc8923e-b7db-40a5-b22a-a975ca2bf1fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-1393-1681511393011 in 1 BLISTER PACKHistorical