Prescription drug · NDA AUTHORIZED GENERIC
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium NDC 0781-4075
Kit · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-4075-15 | 00781407515 | 3 BLISTER PACK in 1 CARTON (0781-4075-15) / 1 KIT in 1 BLISTER PACK (0781-4075-52)Marketed from Oct 12, 2016 |
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)
- Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium
- Generic name (nonproprietary)
- drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
- Dosage form
- Kit
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022532
- Marketing start
- Listing expires
- Identifiers
- Product ID 0781-4075_4f8e8c46-a43e-4b73-b4d2-63076f27113dSPL ID 4f8e8c46-a43e-4b73-b4d2-63076f27113dSPL set ID 58cd12d3-39b1-4375-b7e0-09ba2378a52bRxCUI 1013626, 1013628, 1013629
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
N400781407515followed by a unit qualifier and the quantityPackage 00781-4075-15. 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)
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: • Prevent pregnancy. ( 1.1 ) • Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.2 ) • Treat moderate acne for females of reproductive potential at least 14 years old only if the patient desires an oral contraceptive for birth control. ( 1.3 ) • Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contracept…
Excerpt only. Read the full label for complete information.
About NDC 0781-4075
- What is NDC 0781-4075?
- 0781-4075 is the product NDC for Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium kit, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium?
- 1 other product NDC are listed under this name. See all Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium | — | Kit | Sandoz Inc | 0781-4103 | 00781-4103-15 |
Other NDCs under NDA 022532
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 |
|---|---|---|---|---|
| Beyazdrospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium | — | Kit | Bayer HealthCare Pharmaceuticals Inc. | 50419-407 |