FDA.reportPublic FDA data

Ngenla

Product NDC
0069-0505
11-digit product format
000690505
Labeler code
0069
Product ID
0069-0505_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
24 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
IngredientStrength
SOMATROGON24 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
0069-0505-01Ngenla1.2 mL in 1 CARTRIDGEINJECTION, SOLUTION1.212
0069-0505-02Ngenla1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0505-01ML - Milliliter0069-05053ea459c3-c09f-416c-9668-31211dc6ecbe12023-08-08
0069-0505-02ML - Milliliter0069-0505a1e28261-5f2d-42d0-962c-bc1f28b78d5712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0505NGENLA (SOMATROGON-GHLA) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]8Current NDC, 2 package rows20250101_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NgenlaSOMATROGON-GHLAPfizer Laboratories Div Pfizer Inc06dce529-b741-4a1b-8842-3ad77be6e3082026-08-14Warnings, Adverse reactionsExact identifier
application number: BLA761184
ndc (product): 0069-0505

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761184Ngenlasomatrogon-ghla351(a)Rx2026-08-01

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
0069-0505-01000690505011.2 mL in 1 CARTRIDGE1.2 mlHistorical
0069-0505-02000690505021 CARTRIDGE in 1 CARTON (0069-0505-02) / 1.2 mL in 1 CARTRIDGE (0069-0505-01) 1 cartridge2023-07-31NoNoCurrent