Identity
- Trade Name
- Premarin (conjugated estrogens) vaginal cream FDA UDI
- Generic Name
- Vaginal applicator, reusable FDA UDI
- Device Name
- PREMARIN (conjugated estrogens) Vaginal Cream—Each gram contains 0.625 mg conjugated estrogens, USP. Combination package: Each contains a net wt. of 1.06 oz (30 g) tube with plastic applicator(s) calibrated in 0.5 g increments to a maximum of 2 g FDA UDI
- Model / Reference
- NDC 0046-0872-21 FDA UDI
- Description
- PREMARIN (conjugated estrogens) Vaginal Cream—Each gram contains 0.625 mg conjugated estrogens, USP. Combination package: Each contains a net wt. of 1.06 oz (30 g) tube with plastic applicator(s) calibrated in 0.5 g increments to a maximum of 2 g FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00300460872217 FDA UDI
- FDA Product Code
- HGD FDA UDI
- GMDN Term
- Vaginal applicator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4520 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal applicator, reusable
Premarin (conjugated estrogens) vaginal cream by Wyeth Pharmaceuticals LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wyeth Pharmaceuticals LLC
Sources (1)
- FDA UDI a4f65849-1c88-41eb-81de-aa3bda675fc7 34 fields · synced May 30, 2026