FDA.reportPublic FDA data

Nivestym

Product NDC
0069-0294
11-digit product format
000690294
Labeler code
0069
Product ID
0069-0294_e73179c2-1306-443c-a5ed-d2748e96147c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
filgrastim-aafi
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA761080
Marketing category
BLA
Marketing start
2019-03-11
Substance
FILGRASTIM
Active strength
480 ug/1.6mL
Pharmacologic classes
Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nivestym
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FILGRASTIM480 ug/1.6mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PVI5M0M1GWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2057200Internal RxNorm lookup
2057205Internal RxNorm lookup
2057209Internal RxNorm lookup
2057212Internal RxNorm lookup
2057215Internal RxNorm lookup
2057216Internal RxNorm lookup
2057218Internal RxNorm lookup
2057219Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d23ab39c-b6ec-41cf-a529-9dd2852c9d9aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f366651-2cb6-4932-a760-2ae84fd8fbffProduct name120230703
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
3b1c6100-f679-4300-94a6-3b3fc05b0c44Product name120230110
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0294-01ML - Milliliter0069-0294a58096a7-fe54-4a94-b276-4ed6e914f84312019-03-12
0069-0294-10ML - Milliliter0069-02947ad2606c-692c-4cfe-9e50-6281fe23aff412019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0294NIVESTYM (FILGRASTIM-AAFI) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]16Current NDC, Legacy NDC20240301_d23ab39c-b6ec-41cf-a529-9dd2852c9d9a.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
NivestymFILGRASTIM-AAFIPfizer Laboratories Div Pfizer Incd23ab39c-b6ec-41cf-a529-9dd2852c9d9a2025-08-12Warnings, Adverse reactionsExact identifier
application number: BLA761080
ndc (product): 0069-0294

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761080Nivestymfilgrastim-aafi351(k) BiosimilarRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2057200filgrastim-aafi 300 MCG in 0.5 ML Prefilled SyringePSNd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057209filgrastim-aafi 300 MCG in 1 ML InjectionPSNd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057215filgrastim-aafi 480 MCG in 0.8 ML Prefilled SyringePSNd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057218filgrastim-aafi 480 MCG in 1.6 ML InjectionPSNd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057205Nivestym 300 MCG in 0.5 ML Prefilled SyringePSNd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057212Nivestym 300 MCG in 1 ML InjectionPSNd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057216Nivestym 480 MCG in 0.8 ML Prefilled SyringePSNd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057219Nivestym 480 MCG in 1.6 ML InjectionPSNd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
20572050.5 ML filgrastim-aafi 0.6 MG/ML Prefilled Syringe [Nivestym]SBDd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
20572160.8 ML filgrastim-aafi 0.6 MG/ML Prefilled Syringe [Nivestym]SBDd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
20572121 ML filgrastim-aafi 0.3 MG/ML Injection [Nivestym]SBDd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
20572191.6 ML filgrastim-aafi 0.3 MG/ML Injection [Nivestym]SBDd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
20572000.5 ML filgrastim-aafi 0.6 MG/ML Prefilled SyringeSCDd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
20572150.8 ML filgrastim-aafi 0.6 MG/ML Prefilled SyringeSCDd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
20572091 ML filgrastim-aafi 0.3 MG/ML InjectionSCDd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
20572181.6 ML filgrastim-aafi 0.3 MG/ML InjectionSCDd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057209filgrastim-aafi 0.3 MG/ML per 1 ML InjectionSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057218filgrastim-aafi 0.3 MG/ML per 1.6 ML InjectionSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057200filgrastim-aafi 0.6 MG/ML per 0.5 ML Prefilled SyringeSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057215filgrastim-aafi 0.6 MG/ML per 0.8 ML Prefilled SyringeSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057200filgrastim-aafi 300 MCG per 0.5 ML Prefilled SyringeSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057209filgrastim-aafi 300 MCG per 1 ML InjectionSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057215filgrastim-aafi 480 MCG per 0.8 ML Prefilled SyringeSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057218filgrastim-aafi 480 MCG per 1.6 ML InjectionSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057212Nivestym 0.3 MG/ML per 1 ML InjectionSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057219Nivestym 0.3 MG/ML per 1.6 ML InjectionSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057205Nivestym 0.6 MG/ML per 0.5 ML Prefilled SyringeSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057216Nivestym 0.6 MG/ML per 0.8 ML Prefilled SyringeSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057205Nivestym 300 MCG per 0.5 ML Prefilled SyringeSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057212Nivestym 300 MCG per 1 ML InjectionSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057216Nivestym 480 MCG per 0.8 ML Prefilled SyringeSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18
2057219Nivestym 480 MCG per 1.6 ML InjectionSYd23ab39c-b6ec-41cf-a529-9dd2852c9d9a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-0294-100006902941010 VIAL, SINGLE-DOSE in 1 CARTON (0069-0294-10) / 1.6 mL in 1 VIAL, SINGLE-DOSE (0069-0294-01) 2019-03-110000-00-00NoNoCurrent