Prescription drug · NDA
Yaz (Drospirenone and ethinyl estradiol) NDC 50419-405
Kit · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-405-03 | 5041904050350419040503 | 3 BLISTER PACK in 1 PACKAGE (50419-405-03) / 1 KIT in 1 BLISTER PACKMarketed from Mar 16, 2007 |
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)
- Yaz
- Generic name (nonproprietary)
- drospirenone and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021676
- Marketing start
- Listing expires
- Identifiers
- Product ID 50419-405_4f14f9c9-411b-48b0-a3d3-cac639cdfb8bSPL ID 4f14f9c9-411b-48b0-a3d3-cac639cdfb8bSPL set ID 065f33e4-b587-4e66-b896-ca9ab7b7c876RxCUI 630734, 748797, 748798, 748856
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
N450419040503followed by a unit qualifier and the quantityPackage 50419-0405-03. 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)
Yaz is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, 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 women at least 14 years old only if the patient desires an oral contraceptive for birth control. ( 1.3 ) 1.1 Oral Contraceptive Yaz ® is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Yaz is also indicated for the treatment of symptoms of premenstrual dysphoric …
Excerpt only. Read the full label for complete information.
About NDC 50419-405
- What is NDC 50419-405?
- 50419-405 is the product NDC for Yaz kit, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Yaz (Drospirenone and ethinyl estradiol).
- 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 Yaz?
- 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.