Theophylline

Product NDC
42858-701
11-digit product format
428580701
Labeler code
42858
Product ID
42858-701_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
400 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

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#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-701THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]8Legacy NDC20230919_bba266d2-1d22-49a9-b3db-e4f06802a8a9.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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42858-701-0142858070101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42858-701-01) 2012-02-020000-00-00NoNoCurrent