Morphine sulfate

Product NDC
63629-1090
11-digit product format
636291090
Labeler code
63629
Product ID
63629-1090_2eda88c1-507f-412c-a4b2-bc329f5b42e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078761
Marketing category
ANDA
Marketing start
2012-05-11
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
100 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1090-1EA - Each63629-10901b78139b-dbd1-4580-9f19-1b676b0be54d12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1090MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]11Legacy NDC20240612_f43fc204-2056-4f0d-8266-ddbd86b0da08.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1090-163629109001100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-1090-1) 2012-05-110000-00-00NoNoCurrent