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 | 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 | 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#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) | Fenwal, Inc. | 4a08a9ec-46a5-4fcf-80ee-5c33f1a8b746 | 2022-11-01 | 593YOG76RN | |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | b45e9f1d-9c48-4b46-8541-d846b89540df | 2022-10-26 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye wash | PURIFIED WATER | McKesson | bd089fde-24ba-4de5-e053-2995a90a39bb | 2022-10-18 | Warnings | 059QF0KO0R |
| Bach Original Flower Remedies Rock Water | WATER | Nelson Bach USA Limited | ea242559-1618-3354-e053-2a95a90a1a95 | 2022-10-03 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Medical Purchasing Solutions, LLC | e90b47e3-9636-b9ee-e053-2a95a90ad48c | 2022-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Company | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 2022-08-04 | Boxed warning, Warnings, Adverse reactions | TE7660XO1C |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Phosphates | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | Fresenius Kabi USA, LLC | 5bf47be3-f3fe-452b-8113-941796498345 | 2022-03-31 | Warnings, Adverse reactions | 22ADO53M6F 593YOG76RN |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Sterile Diluent for Treprostinil | WATER | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | d763511e-f1a7-4014-94b9-f7ad8f023ff4 | 2021-12-02 | 593YOG76RN | |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | cf9f43a0-c750-4cf0-ac49-176ab2105aab | 2021-12-02 | 593YOG76RN | |
| InterSol | PLATELET ADDITIVE 3 | Fenwal, Inc. | e4f06c0b-7cb1-49c9-97a4-2cfc21298495 | 2021-11-16 | Warnings, Adverse reactions | 593YOG76RN |
| Solucion InterSol | SOLUCION ADITIVA PARA PLAQUETAS 3 | Fenwal, Inc. | d5eaf5f4-67d3-4475-af9a-f5b0f882f5d1 | 2021-10-04 | Warnings, Adverse reactions | 593YOG76RN |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | B. Braun Medical Inc. | 8924e52e-8622-4ed6-a061-1908183e0a18 | 2021-08-06 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Phosphates | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | Fresenius Kabi USA, LLC | e6169d3b-39d2-47f9-8d5b-b53ec069a722 | 2021-07-23 | Warnings, Adverse reactions | 22ADO53M6F 593YOG76RN |
| Eyewash | EYEWASH | Global Equipment Company | c4f78121-4668-2e0c-e053-2995a90ab6c6 | 2021-06-17 | Warnings | 059QF0KO0R |
| CLINIMIX E | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE | Baxter Healthcare Company | 8469d6fb-d6ef-476f-8cc3-0905192de0a8 | 2021-04-13 | Warnings, Adverse reactions | TE7660XO1C |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.