Morphine sulfate

Product NDC
55700-825
11-digit product format
557000825
Labeler code
55700
Product ID
55700-825_56be9080-3b73-4cfd-a919-ab38b45d4874
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA078761
Marketing category
ANDA
Marketing start
2020-06-06
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
30 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-825-30EA - Each55700-8251b56947a-40f0-4c88-9659-4000ca11cdac12020-07-13
55700-825-60EA - Each55700-825a9a13cc2-7aec-4888-a0c6-330f705ed58312020-07-13
55700-825-90EA - Each55700-8254202a5ee-79c2-41b8-955e-b3d2b91c449412020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-825-305570008253030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-825-30) 2020-06-060000-00-00NoNoCurrent
55700-825-605570008256060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-825-60) 2020-06-060000-00-00NoNoCurrent
55700-825-905570008259090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-825-90) 2020-07-210000-00-00NoNoCurrent