Prescription drug · NDA
Safyral NDC 50419-403
drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium · Kit · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-403-00 | 50419040300 | 90 BLISTER PACK in 1 PACKAGE (50419-403-00) / 1 KIT in 1 BLISTER PACKMarketed from Feb 13, 2012 | |
| 50419-403-03 | 50419040303 | 3 BLISTER PACK in 1 PACKAGE (50419-403-03) / 1 KIT in 1 BLISTER PACK (50419-403-01)Marketed from Feb 13, 2012 | |
| 50419-403-70 | 50419040370 | 90 BLISTER PACK in 1 PACKAGE (50419-403-70) / 1 KIT in 1 BLISTER PACKMarketed from Feb 13, 2012 | |
| 50419-403-75 | 50419040375 | 12 PACKAGE in 1 CARTON (50419-403-75) / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-403-71)Marketed from Feb 13, 2012 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Safyral
- Generic name (nonproprietary)
- drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
- Dosage form
- Kit
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022574
- Marketing start
- Listing expires
- Identifiers
- Product ID 50419-403_e2c77609-66d5-4e76-8f2b-060c9e30b5e9SPL ID e2c77609-66d5-4e76-8f2b-060c9e30b5e9SPL set ID 97563516-306a-4e17-9690-edbda49ecd83RxCUI 1013628, 1050492, 1050493, 1050494
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
N450419040300followed by a unit qualifier and the quantityPackage 50419-0403-00. 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)
Safyral 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 Safyral is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Folate Supplementation Safyral is indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceiv…
Excerpt only. Read the full label for complete information.
About NDC 50419-403
- What is NDC 50419-403?
- 50419-403 is the product NDC for Safyral kit, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Safyral (Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium).
- Who is the labeler?
- Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Safyral?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium | — | Kit | Sandoz Inc | 0781-4103 |