FDA.reportPublic FDA data

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NgenlaSOMATROGON-GHLAPfizer Laboratories Div Pfizer Inc06dce529-b741-4a1b-8842-3ad77be6e3082026-05-07Warnings, Adverse reactionsExact identifier
application number: BLA761184
ndc (product): 0069-0520

Additional Listing Data#

Finished product
Yes
Brand name base
Ngenla
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOMATROGON60 mg/1.2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6D848RA61BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2644517Internal RxNorm lookup
2644523Internal RxNorm lookup
2644526Internal RxNorm lookup
2644529Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06dce529-b741-4a1b-8842-3ad77be6e308Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92184b7a-bedb-4b8f-916d-c1126d22385fProduct name120231030
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0520-01Ngenla1.2 mL in 1 CARTRIDGEINJECTION, SOLUTION1.212
0069-0520-02Ngenla1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0520-01ML - Milliliter0069-0520e403af9e-093c-4991-a659-5cd6bba88e5f12023-09-05
0069-0520-02ML - Milliliter0069-0520908ad963-1746-43ee-8102-f80fa1dfc33512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0520NGENLA (SOMATROGON-GHLA) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]8Current NDC, 2 package rows20250101_06dce529-b741-4a1b-8842-3ad77be6e308.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761184Ngenlasomatrogon-ghla351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2644523Ngenla 24 MG in 1.2 ML Pen InjectorPSN06dce529-b741-4a1b-8842-3ad77be6e30812
2644529Ngenla 60 MG in 1.2 ML Pen InjectorPSN06dce529-b741-4a1b-8842-3ad77be6e30812
2644517somatrogon-ghla 24 MG in 1.2 ML Pen InjectorPSN06dce529-b741-4a1b-8842-3ad77be6e30812
2644526somatrogon-ghla 60 MG in 1.2 ML Pen InjectorPSN06dce529-b741-4a1b-8842-3ad77be6e30812
26445231.2 ML somatrogon-ghla 20 MG/ML Pen Injector [Ngenla]SBD06dce529-b741-4a1b-8842-3ad77be6e30812
26445291.2 ML somatrogon-ghla 50 MG/ML Pen Injector [Ngenla]SBD06dce529-b741-4a1b-8842-3ad77be6e30812
26445171.2 ML somatrogon-ghla 20 MG/ML Pen InjectorSCD06dce529-b741-4a1b-8842-3ad77be6e30812
26445261.2 ML somatrogon-ghla 50 MG/ML Pen InjectorSCD06dce529-b741-4a1b-8842-3ad77be6e30812
2644523Ngenla 20 MG/ML per 1.2 ML Pen InjectorSY06dce529-b741-4a1b-8842-3ad77be6e30812
2644523Ngenla 24 MG per 1.2 ML Pen InjectorSY06dce529-b741-4a1b-8842-3ad77be6e30812
2644529Ngenla 50 MG/ML per 1.2 ML Pen InjectorSY06dce529-b741-4a1b-8842-3ad77be6e30812
2644529Ngenla 60 MG per 1.2 ML Pen InjectorSY06dce529-b741-4a1b-8842-3ad77be6e30812
2644517somatrogon-ghla 20 MG/ML per 1.2 ML Pen InjectorSY06dce529-b741-4a1b-8842-3ad77be6e30812
2644517somatrogon-ghla 24 MG per 1.2 ML Pen InjectorSY06dce529-b741-4a1b-8842-3ad77be6e30812
2644526somatrogon-ghla 50 MG/ML per 1.2 ML Pen InjectorSY06dce529-b741-4a1b-8842-3ad77be6e30812
2644526somatrogon-ghla 60 MG per 1.2 ML Pen InjectorSY06dce529-b741-4a1b-8842-3ad77be6e30812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0069-0520-01000690520011.2 mL in 1 CARTRIDGE1.2 mlHistorical
0069-0520-02000690520021 CARTRIDGE in 1 CARTON (0069-0520-02) / 1.2 mL in 1 CARTRIDGE (0069-0520-01) 1 cartridge2023-07-31NoNoCurrent