Theophylline in Dextrose

Product NDC
0264-9554
11-digit product format
002649554
Labeler code
0264
Product ID
0264-9554_5df8f4d8-1afb-48e9-9175-768cf77c3064
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline Anhydrous and Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA019826
Marketing category
NDA
Marketing start
1992-08-14
Marketing end
0000-00-00
Substance
THEOPHYLLINE ANHYDROUS; DEXTROSE MONOHYDRATE
Active strength
80 mg/100mL; g/100mL
Pharmacologic classes
Methylxanthine [EPC],Xanthines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0264-9554-102025-11-14C16284748780-1d6a99b39-8299-a426-e053-dadaa90af4c2c3bb34c1-89b2-48c3-9ad2-16b4b2bce5f9
0264-9554-102022-01-28C16284748780-1d6a99b39-8299-a426-e053-dadaa90af4c2c3bb34c1-89b2-48c3-9ad2-16b4b2bce5f9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-9554-10ML - Milliliter0264-9554d032bb7b-e522-4bf4-a257-40822a0fcb3712012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-9554THEOPHYLLINE IN DEXTROSE (THEOPHYLLINE ANHYDROUS AND DEXTROSE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]12Legacy NDC20170818_c3bb34c1-89b2-48c3-9ad2-16b4b2bce5f9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-9554-100026495541024 CONTAINER in 1 CASE (0264-9554-10) > 500 mL in 1 CONTAINER24 container1992-08-140000-00-00NoNoCurrent