gonal-f rff redi-ject

Generic: follitropin

Labeler: emd serono, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name gonal-f rff redi-ject
Generic Name follitropin
Labeler emd serono, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

follitropin 300 [iU]/.5mL

Manufacturer
EMD Serono, Inc.

Identifiers & Regulatory

Product NDC 44087-1115
Product ID 44087-1115_657d712c-ea55-4e2b-9111-ed8dc792887b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021684
Listing Expiration 2026-12-31
Marketing Start 2013-10-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 440871115
Hyphenated Format 44087-1115

Supplemental Identifiers

RxCUI
1594334 1594418 1594432 1654171 1654179 1654184
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 gonal-f rff redi-ject (source: ndc)
Generic Name follitropin (source: ndc)
Application Number BLA021684 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 300 [iU]/.5mL
source: ndc
Packaging
  • 1 PACKAGE in 1 CARTON (44087-1115-1) / .5 mL in 1 PACKAGE
source: ndc

Packages (1)

44087-1115-1 1 PACKAGE in 1 CARTON (44087-1115-1) / .5 mL in 1 PACKAGE

Ingredients (1)

follitropin (300 [iU]/.5mL)

Linked Drug Pages (1)

Gonal-f RFF Redi-ject ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "657d712c-ea55-4e2b-9111-ed8dc792887b", "openfda": {"nui": ["N0000175838", "M0009540"], "unii": ["076WHW89TW"], "rxcui": ["1594334", "1594418", "1594432", "1654171", "1654179", "1654184"], "spl_set_id": ["b6d11c45-b502-478e-bb28-2ff596ea259c"], "pharm_class_cs": ["Gonadotropins [CS]"], "pharm_class_epc": ["Gonadotropin [EPC]"], "manufacturer_name": ["EMD Serono, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 PACKAGE in 1 CARTON (44087-1115-1)  / .5 mL in 1 PACKAGE", "package_ndc": "44087-1115-1", "marketing_start_date": "20131016"}], "brand_name": "Gonal-f RFF Redi-ject", "product_id": "44087-1115_657d712c-ea55-4e2b-9111-ed8dc792887b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Gonadotropin [EPC]", "Gonadotropins [CS]"], "product_ndc": "44087-1115", "generic_name": "FOLLITROPIN", "labeler_name": "EMD Serono, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gonal-f RFF Redi-ject", "active_ingredients": [{"name": "FOLLITROPIN", "strength": "300 [iU]/.5mL"}], "application_number": "BLA021684", "marketing_category": "BLA", "marketing_start_date": "20131016", "listing_expiration_date": "20261231"}