Prescription drug · ANDA
Estradiol Vaginal (Estradiol) NDC 63629-8654
Estradiol .1 mg/g · Cream · Vaginal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8654-1 | 6362986540163629865401 | 1 TUBE in 1 CARTON (63629-8654-1) / 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 PrepackNDC labeler code 63629
- 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 63629-8654_5ba30fb0-8d08-4f8b-92ef-6af874d3413eSPL ID 5ba30fb0-8d08-4f8b-92ef-6af874d3413eSPL set ID e7b15ec3-e195-44a6-bdd7-9b6de2b235b8RxCUI 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
N463629865401followed by a unit qualifier and the quantityPackage 63629-8654-01. 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.
About NDC 63629-8654
- What is NDC 63629-8654?
- 63629-8654 is the product NDC for Estradiol Vaginal (estradiol), Estradiol .1 mg/g cream, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Estradiol Vaginal (Estradiol).
- What is the active ingredient?
- Estradiol.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Estradiol Vaginal?
- 10 other product NDCs are listed under this name. See all Estradiol Vaginal NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Estradiol Vaginal products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Estradiol Vaginalestradiol | Estradiol hemihydrate .1 mg/g | CreamVaginal | Encube Ethicals, Inc. | 21922-085 | 21922-0085-06 |
| Estradiol Vaginalestradiol | Estradiol hemihydrate .1 mg/g | CreamVaginal | Redpharm Drug | 67296-2303 | 67296-2303-04 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | A-S Medication Solutions | 50090-6811 | 50090-6811-00 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | AvKARE | 42291-426 | 42291-0426-42 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | Padagis Israel Pharmaceuticals Ltd | 45802-097 | 45802-0097-35 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | A-S Medication Solutions | 50090-7266 | 50090-7266-00 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | Redpharm Drug | 67296-2258 | 67296-2258-04 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | NuCare Pharmaceuticals, Inc. | 68071-3796 | 68071-3796-04 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | Bryant Ranch Prepack | 71335-2831 | 71335-2831-01 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | Bryant Ranch Prepack | 72162-1389 | 72162-1389-02 |
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 | AvKARE | 42291-426 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | Padagis Israel Pharmaceuticals Ltd | 45802-097 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | A-S Medication Solutions | 50090-7266 |
| Estradiol Vaginalestradiol | Estradiol .1 mg/g | CreamVaginal | Redpharm Drug | 67296-2258 |
| 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 | Bryant Ranch Prepack | 72162-1389 |