Home NDC 0069-0520 Ngenla
Product NDC 0069-0520
11-digit product format 000690520
Labeler code 0069
Product ID 0069-0520_28203f91-b3df-4b23-907a-10c061afbaf1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name somatrogon-ghla
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Pfizer Laboratories Div Pfizer Inc
Application BLA761184
Marketing category BLA
Marketing start 2023-07-31
Substance SOMATROGON
Active strength 60 mg/1.2mL
Pharmacologic classes 11-beta Hydroxysteroid Dehydrogenase Type 1 Inhibitors [MoA], Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Ngenla
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SOMATROGON 60 mg/1.2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6D848RA61B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2644517 Internal RxNorm lookup 2644523 Internal RxNorm lookup 2644526 Internal RxNorm lookup 2644529 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-0520-01 Ngenla 1.2 mL in 1 CARTRIDGE INJECTION, SOLUTION 1.2 12 0069-0520-02 Ngenla 1 in 1 CARTON INJECTION, SOLUTION 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-0520 NGENLA (SOMATROGON-GHLA) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 8 Current NDC, 2 package rows 20250101_06dce529-b741-4a1b-8842-3ad77be6e308.zip
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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ngenla SOMATROGON-GHLA Pfizer Laboratories Div Pfizer Inc 06dce529-b741-4a1b-8842-3ad77be6e308 2026-08-14 Warnings, Adverse reactions Exact identifier application number: BLA761184 ndc (product): 0069-0520
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761184 Ngenla somatrogon-ghla 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0069-0520-01 00069052001 1.2 mL in 1 CARTRIDGE 1.2 ml Historical 0069-0520-02 00069052002 1 CARTRIDGE in 1 CARTON (0069-0520-02) / 1.2 mL in 1 CARTRIDGE (0069-0520-01) 1 cartridge 2023-07-31 No No Current