NDC 0009-5201 - SOMAVERT

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0009-5201
Package NDCs from labels: 0009-5201-04
Manufacturer: Pharmacia & Upjohn Company LLC | Pfizer Manufacturing Belgium NV | Pfizer Ireland Pharmaceuticals Unlimited Company
Effective date: 2025-12-18
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
SOMAVERT	Pharmacia & Upjohn Company LLC \| Pfizer Manufacturing Belgium NV \| Pfizer Ireland Pharmaceuticals Unlimited Company	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL
SOMAVERT	Pharmacia and Upjohn Company LLC \| FUJIFILM Diosynth Biotechnologies U.S.A., Inc \| Baxter Healthcare Corporation \| Pfizer Manufacturing Belgium NV \| Pfizer Ireland Pharmaceuticals \| Amgen Technology (ireland) Unlimited Company	2020-04-16	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0009-5201-04	SOMAVERT	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1 mL	25 mg in 1mL	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-5201	SOMAVERT (PEGVISOMANT) KIT [PHARMACIA & UPJOHN COMPANY LLC]	11	Unmatched	20240413_3cbb485b-6df1-49ce-8747-592b395b1988.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PEGVISOMANT	ACTIVE INGREDIENT	N824AOU5XV	SOMAVERT (PEGVISOMANT) KIT [PHARMACIA AND UPJOHN COMPANY]	18
PEGVISOMANT	ACTIVE MOIETY	N824AOU5XV	SOMAVERT (PEGVISOMANT) KIT [PHARMACIA AND UPJOHN COMPANY]	18
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	SOMAVERT (PEGVISOMANT) KIT [PHARMACIA AND UPJOHN COMPANY]	18
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	SOMAVERT (PEGVISOMANT) KIT [PHARMACIA AND UPJOHN COMPANY]	18
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	SOMAVERT (PEGVISOMANT) KIT [PHARMACIA AND UPJOHN COMPANY]	18
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	SOMAVERT (PEGVISOMANT) KIT [PHARMACIA AND UPJOHN COMPANY]	18

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 13 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
URELLE	HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	Viatris Specialty LLC	1d80a11c-6f86-403b-85d4-32ec1924dbe9	2015-01-13	Warnings, Adverse reactions	Exact identifier unii: 593YOG76RN
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	051f7347-5a76-4664-8fe2-e61b3dfcb0e4	2014-08-27		Exact identifier unii: 593YOG76RN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.