Prescription drug · ANDA
Estradiol Vaginal (estradiol) NDC 72162-1389
Estradiol .1 mg/g · Cream · Vaginal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1389-2 | 72162138902 | 1 TUBE in 1 CARTON (72162-1389-2) / 42.5 g in 1 TUBEMarketed from Jan 6, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — .1 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210194
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72162-1389_3f3bbc65-e965-4cfb-b133-df4100964d6aSPL ID 3f3bbc65-e965-4cfb-b133-df4100964d6aSPL set ID 67f581cb-6d77-49fc-b2f3-976e3b57dcbfRxCUI 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
N472162138902followed by a unit qualifier and the quantityPackage 72162-1389-02. 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, 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 210194
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 | NuCare Pharmaceuticals, Inc. | 68071-3796 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | Bryant Ranch Prepack | 71335-2831 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | AvKARE | 42291-426 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | Padagis Israel Pharmaceuticals Ltd | 45802-097 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | Bryant Ranch Prepack | 63629-8654 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | Redpharm Drug | 67296-2258 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | A-S Medication Solutions | 50090-7266 |