Prescription drug · ANDA
Estrace (Estradiol) NDC 0430-3754
Estradiol .1 mg/g · Cream · Vaginal · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0430-3754-14 | 00430375414 | 36 CARTON in 1 CASE (0430-3754-14) / 1 TUBE, WITH APPLICATOR in 1 CARTON / 42.5 g in 1 TUBE, WITH APPLICATORMarketed from Jul 1, 2001 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Estrace
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — .1 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- Allergan, Inc.NDC labeler code 0430
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086069
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0430-3754_4d3bc996-2273-415e-9fc1-158037932e15SPL ID 4d3bc996-2273-415e-9fc1-158037932e15SPL set ID dfc41fcd-c5ba-4b25-b647-cf04d3988b3eRxCUI 310169, 890918UNII 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
N400430375414followed by a unit qualifier and the quantityPackage 00430-3754-14. 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 ESTRACE (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.
About NDC 0430-3754
- What is NDC 0430-3754?
- 0430-3754 is the product NDC for Estrace (estradiol), Estradiol .1 mg/g cream, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Estrace (Estradiol).
- What is the active ingredient?
- Estradiol.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0430. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Estrace?
- 1 other product NDC are listed under this name. See all Estrace NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Estrace products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Estraceestradiol | Estradiol .1 mg/g | CreamVaginal | A-S Medication Solutions | 50090-2321 | 50090-2321-00 |
Other NDCs under ANDA 086069
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 |
|---|---|---|---|---|
| Estraceestradiol | Estradiol .1 mg/g | CreamVaginal | A-S Medication Solutions | 50090-2321 |
| Estradiol | Estradiol .1 mg/g | CreamVaginal | A-S Medication Solutions | 50090-3327 |
| Estradiol | Estradiol .1 mg/g | CreamVaginal | Teva Pharmaceuticals USA, Inc. | 0093-3541 |