Theophylline

Product NDC
63629-7169
11-digit product format
636297169
Labeler code
63629
Product ID
63629-7169_f5b20012-0011-4727-a540-950065025a3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7169-12020-10-16C16284748780-19d75b9d0-567a-f424-e053-dadaa90a57ced7fff827-366c-4a34-bc94-f443f9451c7d
63629-7169-12020-01-31C16284748780-19d75b9d0-567a-f424-e053-dadaa90a57ced7fff827-366c-4a34-bc94-f443f9451c7d

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7169-16362971690130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7169-1) 2016-12-290000-00-00NoNoCurrent