NDC 0052-0316
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 | 0052-0316_19e6b8fb-87e6-4dca-96c4-3cf8385533c1 |
| NDC | 0052-0316 |
| 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 | 650 [iU]/.78mL |
| Pharm Classes | Gonadotropin [EPC], Gonadotropins [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 0052-0316-01
1 KIT in 1 CARTON (0052-0316-01) > 1 CARTRIDGE in 1 KIT > .78 mL in 1 CARTRIDGE
| Marketing Start Date | 2004-03-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0052-0316-81 [00052031681]
Follistim AQ INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021211 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2004-03-24 |
NDC 0052-0316-01 [00052031601]
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 | 650 [iU]/.78mL |
OpenFDA Data
| SPL SET ID: | 96f11b5d-cc7b-48aa-830a-a28e1962d871 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
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 |
Trademark Results [Follistim AQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FOLLISTIM AQ 78584155 3166497 Live/Registered |
MERCK SHARP & DOHME B.V. 2005-03-10 |
 FOLLISTIM AQ 76170241 not registered Dead/Abandoned |
N.V. Organon 2000-11-22 |
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