FDA.reportPublic FDA data

HYMPAVZI

Product NDC
0069-1510
11-digit product format
000691510
Labeler code
0069
Product ID
0069-1510_a13e8012-656c-4e2a-b43a-2f3366a28ffb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
marstacimab-hncq
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA761369
Marketing category
BLA
Marketing start
2025-10-16
Substance
MARSTACIMAB
Active strength
150 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MARSTACIMAB150 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0UB3OA67O7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2697139Internal RxNorm lookup
2697146Internal RxNorm lookup
2697150Internal RxNorm lookup
2697154Internal RxNorm lookup
2745185Internal RxNorm lookup
2745186Internal RxNorm lookup
2745187Internal RxNorm lookup
2745188Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2cc631e-13a6-40c2-acf9-065ccedfb90aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
375f9f27-7c4e-49d8-9b04-0e1f4cd1209bProduct name120250505
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-1510-01HYMPAVZI1 mL in 1 SYRINGEINJECTION, SOLUTION15
0069-1510-01HYMPAVZI1 in 1 CARTONINJECTION, SOLUTION15

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
HYMPAVZIMARSTACIMAB-HNCQPfizer Laboratories Div Pfizer Inca2cc631e-13a6-40c2-acf9-065ccedfb90a2026-06-22Warnings, Adverse reactionsExact identifier
application number: BLA761369
ndc (product): 0069-1510

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761369Hympavzimarstacimab-hncq351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2697146HYMPAVZI 150 MG in 1 ML Auto-InjectorPSNa2cc631e-13a6-40c2-acf9-065ccedfb90a5
2697154HYMPAVZI 150 MG in 1 ML Prefilled SyringePSNa2cc631e-13a6-40c2-acf9-065ccedfb90a5
2697139marstacimab-hncq 150 MG in 1 ML Auto-InjectorPSNa2cc631e-13a6-40c2-acf9-065ccedfb90a5
2697150marstacimab-hncq 150 MG in 1 ML Prefilled SyringePSNa2cc631e-13a6-40c2-acf9-065ccedfb90a5
26971461 ML marstacimab-hncq 150 MG/ML Auto-Injector [Hympavzi]SBDa2cc631e-13a6-40c2-acf9-065ccedfb90a5
26971541 ML marstacimab-hncq 150 MG/ML Prefilled Syringe [Hympavzi]SBDa2cc631e-13a6-40c2-acf9-065ccedfb90a5
26971391 ML marstacimab-hncq 150 MG/ML Auto-InjectorSCDa2cc631e-13a6-40c2-acf9-065ccedfb90a5
26971501 ML marstacimab-hncq 150 MG/ML Prefilled SyringeSCDa2cc631e-13a6-40c2-acf9-065ccedfb90a5
26971461 ML Hympavzi 150 MG/ML Auto-InjectorSYa2cc631e-13a6-40c2-acf9-065ccedfb90a5
26971541 ML Hympavzi 150 MG/ML Prefilled SyringeSYa2cc631e-13a6-40c2-acf9-065ccedfb90a5
2697146Hympavzi 150 MG per 1 ML Auto-InjectorSYa2cc631e-13a6-40c2-acf9-065ccedfb90a5
2697154Hympavzi 150 MG per 1 ML Prefilled SyringeSYa2cc631e-13a6-40c2-acf9-065ccedfb90a5
2697139marstacimab-hncq 150 MG per 1 ML Auto-InjectorSYa2cc631e-13a6-40c2-acf9-065ccedfb90a5
2697150marstacimab-hncq 150 MG per 1 ML Prefilled SyringeSYa2cc631e-13a6-40c2-acf9-065ccedfb90a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0069-1510-01000691510011 SYRINGE in 1 CARTON (0069-1510-01) / 1 mL in 1 SYRINGE1 syringe2025-10-16NoNoCurrent