follistim aq

Generic: follitropin

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name follistim aq
Generic Name follitropin
Labeler organon llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

follitropin 300 [iU]/.36mL

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-129
Product ID 78206-129_102132d6-d45e-4333-badb-7545fa87becc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021211
Listing Expiration 2027-12-31
Marketing Start 2023-07-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206129
Hyphenated Format 78206-129

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
  • 300 [iU]/.36mL
source: ndc
Packaging
  • 1 KIT in 1 CARTON (78206-129-01) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-99)
  • 1 KIT in 1 CARTON (78206-129-59) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-58)
source: ndc

Packages (2)

78206-129-01 1 KIT in 1 CARTON (78206-129-01) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-99) 78206-129-59 1 KIT in 1 CARTON (78206-129-59) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-58)

Ingredients (1)

follitropin (300 [iU]/.36mL)

Linked Drug Pages (1)

Follistim AQ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "102132d6-d45e-4333-badb-7545fa87becc", "openfda": {"nui": ["N0000175838", "M0009540"], "unii": ["076WHW89TW"], "rxcui": ["854787", "854788", "854790", "1361563", "1361569", "1361572"], "spl_set_id": ["48489027-e52b-4b10-ae74-4ba03839150c"], "pharm_class_cs": ["Gonadotropins [CS]"], "pharm_class_epc": ["Gonadotropin [EPC]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (78206-129-01)  / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-99)", "package_ndc": "78206-129-01", "marketing_start_date": "20230724"}, {"sample": true, "description": "1 KIT in 1 CARTON (78206-129-59)  / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-58)", "package_ndc": "78206-129-59", "marketing_start_date": "20230724"}], "brand_name": "Follistim AQ", "product_id": "78206-129_102132d6-d45e-4333-badb-7545fa87becc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Gonadotropin [EPC]", "Gonadotropins [CS]"], "product_ndc": "78206-129", "generic_name": "follitropin", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Follistim AQ", "active_ingredients": [{"name": "FOLLITROPIN", "strength": "300 [iU]/.36mL"}], "application_number": "BLA021211", "marketing_category": "BLA", "marketing_start_date": "20230724", "listing_expiration_date": "20271231"}