NDC 0052-0326

Follistim AQ

Follitropin

Follistim AQ is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Llc. The primary component is Follitropin.

• Product ID: 0052-0326_19e6b8fb-87e6-4dca-96c4-3cf8385533c1
• NDC: 0052-0326
• Product Type: Human Prescription Drug
• Proprietary Name: Follistim AQ
• Generic Name: Follitropin
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2004-03-24
• Marketing Category: BLA / NDA
• Application Number: BLA021211
• Labeler Name: Merck Sharp & Dohme LLC
• Substance Name: FOLLITROPIN
• Active Ingredient Strength: 975 [iU]/1.17mL
• Pharm Classes: Gonadotropin [EPC], Gonadotropins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0052-0326-01

1 KIT in 1 CARTON (0052-0326-01) > 1 CARTRIDGE in 1 KIT > 1.17 mL in 1 CARTRIDGE

• Marketing Start Date: 2004-03-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0052-0326-01 [00052032601]

Follistim AQ INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021211
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2004-03-24

Drug Details

Active Ingredients

Ingredient	Strength
FOLLITROPIN	975 [iU]/1.17mL

OpenFDA Data

• SPL SET ID: 96f11b5d-cc7b-48aa-830a-a28e1962d871
• Manufacturer:
  • Organon USA Inc.
• UNII:
  • 076WHW89TW
• RxNorm Concept Unique ID - RxCUI:
  • 1361563
  • 1361569
  • 1361572
  • 854787
  • 854788
  • 854790

Pharmacological Class

• Gonadotropin [EPC]
• Gonadotropins [CS]

NDC Crossover Matching brand name "Follistim AQ" or generic name "Follitropin"

NDC	Brand Name	Generic Name
0052-0313	Follistim AQ	follitropin
0052-0316	Follistim AQ	follitropin
0052-0326	Follistim AQ	follitropin
44087-1115	Gonal-f RFF Redi-ject	FOLLITROPIN
44087-1116	Gonal-f RFF Redi-ject	FOLLITROPIN
44087-1117	Gonal-f RFF Redi-ject	FOLLITROPIN
44087-1118	Gonal-f RFF Redi-ject	FOLLITROPIN