Prescription drug · ANDA
Estradiol Vaginal Cream (estradiol) NDC 66993-002
Estradiol .1 mg/g · Cream · Vaginal · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-002-10 | 66993000210 | 1 TUBE in 1 CARTON (66993-002-10) / 42.5 g in 1 TUBEMarketed from Oct 1, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Estradiol Vaginal Cream
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — .1 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- Prasco Laboratories
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212313
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 66993-002_11e56187-77a7-4d0d-9929-bc4527bac7c0SPL ID 11e56187-77a7-4d0d-9929-bc4527bac7c0SPL set ID c895ac14-5dbd-4201-bf3e-ba7c38a4e994RxCUI 310169UNII 4TI98Z838E
- Pharmacologic class
- Estrogen
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N466993000210followed by a unit qualifier and the quantityPackage 66993-0002-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Estradiol Vaginal Cream, USP, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212313
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | A-S Medication Solutions | 50090-6811 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.