Prescription drug · NDA
Beyaz NDC 50419-407
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 |
|---|---|---|---|
| 50419-407-00 | 50419040700 | 90 BLISTER PACK in 1 PACKAGE (50419-407-00) / 1 KIT in 1 BLISTER PACKMarketed from Oct 7, 2010 | |
| 50419-407-03 | 50419040703 | 3 BLISTER PACK in 1 PACKAGE (50419-407-03) / 1 KIT in 1 BLISTER PACK (50419-407-01)Marketed from Oct 7, 2010 | |
| 50419-407-70 | 50419040770 | 90 BLISTER PACK in 1 PACKAGE (50419-407-70) / 1 KIT in 1 BLISTER PACKMarketed from Oct 7, 2010 | |
| 50419-407-75 | 50419040775 | 12 PACKAGE in 1 CARTON (50419-407-75) / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-407-71)Marketed from Oct 7, 2010 |
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)
- Beyaz
- 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 022532
- Marketing start
- Listing expires
- Identifiers
- Product ID 50419-407_2a018ffb-3fc6-41db-83b3-6e159cd446c3SPL ID 2a018ffb-3fc6-41db-83b3-6e159cd446c3SPL set ID 8132454a-6135-4bac-b206-83a55eb8dbc6RxCUI 1013626, 1013628, 1013629, 1013630UPC 0350419405010
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
N450419040700followed by a unit qualifier and the quantityPackage 50419-0407-00. 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)
Beyaz 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 ) • 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 contraception. ( 1.4 ) 1.1 Oral Contraceptive Beyaz ® is indicated for use by …
Excerpt only. Read the full label for complete information.
About NDC 50419-407
- What is NDC 50419-407?
- 50419-407 is the product NDC for Beyaz 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?
- Beyaz (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 Beyaz?
- 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 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 |
|---|---|---|---|---|
| Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium | — | Kit | Sandoz Inc | 0781-4075 |