NDC Code(s) : 70511-131-05, 70511-131-84
Packager : MAIA Pharmaceuticals, Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sincalide Sincalide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:70511-131
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SINCALIDE(UNII: M03GIQ7Z6P)
(SINCALIDE - UNII:M03GIQ7Z6P) 		SINCALIDE5 ug in 5 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)170 mg in 5 mL
ARGININE HYDROCHLORIDE(UNII: F7LTH1E20Y)30 mg in 5 mL
LYSINE HYDROCHLORIDE(UNII: JNJ23Q2COM)15 mg in 5 mL
METHIONINE(UNII: AE28F7PNPL)4 mg in 5 mL
PENTETIC ACID(UNII: 7A314HQM0I)2 mg in 5 mL
SODIUM METABISULFITE(UNII: 4VON5FNS3C).04 mg in 5 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70511-131-8410 in 1 PACKAGE 25/11/2022
1NDC:70511-131-055 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210850 11/25/2022

LABELER - MAIA Pharmaceuticals, Inc.(079211845)

REGISTRANT - MAIA Pharmaceuticals, Inc.(079211845)

Establishment
Name Address ID/FEI Business Operations
Gland Pharma Limited 918601238 MANUFACTURE(70511-131)

PRINCIPAL DISPLAY PANEL

vial

NDC 70511-131-05

Sincalide for Injection

5 mcg/vial

For Intravenous Use

Vial contains a sterile, lyophilized powder providing 5 mcg sincalide (see insert for inactive ingredients); pH adjusted to 6.5 to 7.5 with hydrochloric acid and/or sodium hydroxide.

Recommended Dosage: See Prescribing Information Single-Dose Vial. Discard Unused Portion.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]

Manufactured for MAIA Pharmaceuticals, Inc.