Prescription drug · NDA
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium NDC 0781-4103
Kit · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-4103-15 | 00781410315 | 3 BLISTER PACK in 1 PACKAGE (0781-4103-15) / 1 KIT in 1 BLISTER PACK (0781-4103-52)Marketed from Aug 1, 2015 |
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 — New Drug ApplicationApplication NDA 022574
- Marketing start
- Listing expires
- Identifiers
- Product ID 0781-4103_6471e7a9-16b1-4b84-a113-fe6ac0ca5640SPL ID 6471e7a9-16b1-4b84-a113-fe6ac0ca5640SPL set ID 6928f186-190d-4c40-beab-81cf80cd45cbRxCUI 1013628, 1050492, 1050493
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
N400781410315followed by a unit qualifier and the quantityPackage 00781-4103-15. 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 is 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 ) • Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.2 ) 1.1 Oral Contraceptive Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Folate Supplementation Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is indicated in females…
Excerpt only. Read the full label for complete information.
About NDC 0781-4103
- What is NDC 0781-4103?
- 0781-4103 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 | 0781-4075 | 00781-4075-15 |
Other NDCs under NDA 022574
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 |
|---|---|---|---|---|
| Safyraldrospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium | — | Kit | Bayer HealthCare Pharmaceuticals Inc. | 50419-403 |