FDA.reportPublic FDA data

Nivestym

Product NDC
0069-0293
11-digit product format
000690293
Labeler code
0069
Product ID
0069-0293_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
300 ug/mL
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
FILGRASTIM300 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPVI5M0M1GW
Rxcui2057200, 2057205, 2057209, 2057212, 2057215, 2057216, 2057218, 2057219

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
0069-0293-01ML - Milliliter0069-02934e8a092c-72e6-4aa0-8567-bcc2fe67ffb912019-03-12
0069-0293-10ML - Milliliter0069-02937a42eeac-d7e0-4b51-aa1d-b7468689aa8612019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0293NIVESTYM (FILGRASTIM-AAFI) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]16Current NDC, Legacy NDC20240301_d23ab39c-b6ec-41cf-a529-9dd2852c9d9a.zip

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
0069-0293-100006902931010 VIAL, SINGLE-DOSE in 1 CARTON (0069-0293-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-0293-01) 2019-03-110000-00-00NoNoCurrent