Theophylline

Product NDC
68151-0667
11-digit product format
681510667
Labeler code
68151
Product ID
68151-0667_29fe6915-377d-4310-ad94-bf6144b849bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA087571
Marketing category
ANDA
Marketing start
2012-02-02
Marketing end
0000-00-00
Substance
THEOPHYLLINE ANHYDROUS
Active strength
400 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
68151-0667-02020-01-31C16284748780-19d75b9d0-e3cb-f424-e053-dadaa90a57ceTheophylline (Anhydrous) Extended-Release Tablets 400 mg and 600 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-0667-0TheophyllineAnhydrous1 in 1 PACKAGETABLET, EXTENDED RELEASE14

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-0667THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20170706_def63108-2e96-446c-a7a8-a65d54de2859.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313291theophylline 400 MG Extended Release Oral TabletPSNdef63108-2e96-446c-a7a8-a65d54de28594
313291theophylline 400 MG Extended Release Oral TabletSCDdef63108-2e96-446c-a7a8-a65d54de28594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-0667-0681510667001 in 1 PACKAGEHistorical