Theophylline

Product NDC
42858-702
11-digit product format
428580702
Labeler code
42858
Product ID
42858-702_f343f33f-000b-42f5-a99f-a1cf52cecbce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rhodes Pharmaceuticals
Application
ANDA040086
Marketing category
ANDA
Marketing start
2012-02-02
Marketing end
0000-00-00
Substance
THEOPHYLLINE ANHYDROUS
Active strength
600 mg/1
Pharmacologic classes
Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-702-01EA - Each42858-702cf265422-ff0d-48bb-a95f-6d79d62e8cbc12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42858-702-0142858070201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42858-702-01) 2012-02-020000-00-00NoNoCurrent