NDC codes

FDA NDC Directory
Product NDC (as listed)50419-407Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50419-0407Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50419-407-005041904070090 BLISTER PACK in 1 PACKAGE (50419-407-00) / 1 KIT in 1 BLISTER PACKMarketed from Oct 7, 2010
50419-407-03504190407033 BLISTER PACK in 1 PACKAGE (50419-407-03) / 1 KIT in 1 BLISTER PACK (50419-407-01)Marketed from Oct 7, 2010
50419-407-705041904077090 BLISTER PACK in 1 PACKAGE (50419-407-70) / 1 KIT in 1 BLISTER PACKMarketed from Oct 7, 2010
50419-407-755041904077512 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

N450419040700 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under NDA 022532
ProductStrengthForm · routeLabelerProduct NDC
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium—KitSandoz Inc0781-4075

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