Quadramet

Product NDC: 11994-016
11-digit product format: 119940016
Labeler code: 11994
Product ID: 11994-016_3f73e214-cad4-4b6d-b1ed-66f1777b57f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: samarium Sm 153 lexidronam
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Lantheus Medical Imaging, Inc.
Application: NDA020570
Marketing category: NDA
Marketing start: 1997-05-19
Marketing end: 0000-00-00
Substance: SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
Active strength: 50 mCi/mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11994-016-01	EA - Each	11994-016	43ab3495-71b6-4718-bede-3437360df95e	1	2017-03-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7389YR3OOV	SAMARIUM SM-153 LEXIDRONAM PENTASODIUM	176669-18-4	SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11994-016-01	11994001601	3 mL in 1 VIAL, SINGLE-DOSE (11994-016-01)	3 ml	1997-05-19	0000-00-00	No	No	Current