follistim aq

Generic: follitropin

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name follistim aq
Generic Name follitropin
Labeler merck sharp & dohme llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

follitropin 650 [iU]/.78mL

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0052-0316
Product ID 0052-0316_26b8bd1e-1779-48bc-ad63-a4e27f15b566
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021211
Listing Expiration 2026-12-31
Marketing Start 2004-03-24

Pharmacologic Class

Established (EPC)
gonadotropin [epc]
Chemical Structure
gonadotropins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00520316
Hyphenated Format 0052-0316

Supplemental Identifiers

RxCUI
854787 854788 854790 1361563 1361569 1361572
UNII
076WHW89TW
NUI
N0000175838 M0009540

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name follistim aq (source: ndc)
Generic Name follitropin (source: ndc)
Application Number BLA021211 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 650 [iU]/.78mL
source: ndc
Packaging
  • 1 KIT in 1 CARTON (0052-0316-01) / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE
  • 1 KIT in 1 CARTON (0052-0316-81) / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE
source: ndc

Packages (2)

0052-0316-01 1 KIT in 1 CARTON (0052-0316-01) / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE 0052-0316-81 1 KIT in 1 CARTON (0052-0316-81) / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE

Ingredients (1)

follitropin (650 [iU]/.78mL)

Linked Drug Pages (1)

Follistim AQ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "26b8bd1e-1779-48bc-ad63-a4e27f15b566", "openfda": {"nui": ["N0000175838", "M0009540"], "unii": ["076WHW89TW"], "rxcui": ["854787", "854788", "854790", "1361563", "1361569", "1361572"], "spl_set_id": ["96f11b5d-cc7b-48aa-830a-a28e1962d871"], "pharm_class_cs": ["Gonadotropins [CS]"], "pharm_class_epc": ["Gonadotropin [EPC]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (0052-0316-01)  / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE", "package_ndc": "0052-0316-01", "marketing_start_date": "20040324"}, {"sample": false, "description": "1 KIT in 1 CARTON (0052-0316-81)  / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE", "package_ndc": "0052-0316-81", "marketing_start_date": "20040324"}], "brand_name": "Follistim AQ", "product_id": "0052-0316_26b8bd1e-1779-48bc-ad63-a4e27f15b566", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Gonadotropin [EPC]", "Gonadotropins [CS]"], "product_ndc": "0052-0316", "generic_name": "follitropin", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Follistim AQ", "active_ingredients": [{"name": "FOLLITROPIN", "strength": "650 [iU]/.78mL"}], "application_number": "BLA021211", "marketing_category": "BLA", "marketing_start_date": "20040324", "listing_expiration_date": "20261231"}