What is NDC 50419-409?

50419-409 is the product NDC for Natazia 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?

Natazia (Estradiol valerate and estradiol valerate/dienogest).

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 Natazia?

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.

Natazia NDC 50419-409 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50419-409Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50419-0409Add 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 NDC	11-digit (billing)	Package
50419-409-00	50419040900	90 BLISTER PACK in 1 PACKAGE (50419-409-00) / 1 KIT in 1 BLISTER PACKMarketed from May 6, 2010
50419-409-03	50419040903	3 BLISTER PACK in 1 PACKAGE (50419-409-03) / 1 KIT in 1 BLISTER PACK (50419-409-01)Marketed from May 6, 2010
50419-409-73	50419040973	5 BLISTER PACK in 1 PACKAGE (50419-409-73) / 1 KIT in 1 BLISTER PACKMarketed from May 6, 2010
50419-409-76	50419040976	2 BLISTER PACK in 1 PACKAGE (50419-409-76) / 1 KIT in 1 BLISTER PACK (50419-409-70)Marketed from May 6, 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): Natazia
Generic name (nonproprietary): estradiol valerate and estradiol valerate/dienogest
Dosage form: Kit
Labeler: Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022252
Marketing start: May 6, 2010
Listing expires: Dec 31, 2026
Identifiers: Product ID 50419-409_3b747381-9764-44a3-a08d-a80cf0988665SPL ID 3b747381-9764-44a3-a08d-a80cf0988665SPL set ID 02c91fba-9c47-43ef-ac78-e82369798834RxCUI 748797, 978941, 978944, 978946, 978948, 978949, 978950

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

N450419040900 followed by a unit qualifier and the quantity

Package 50419-0409-00. 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 Jun 26, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

• Natazia is a combination of dienogest , a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) • The efficacy of Natazia in females of reproductive potential with a body mass index (BMI) of >30 kg/m 2 has not been evaluated. ( 1 , 8.8 ) • Treatment of heavy menstrual bleeding in females of reproductive potential without organic pathology who choose to use an oral contraceptive as their method of contraception. ( 1.2 ) 1.1 Oral Contraception Natazia ® is indicated for use by women to prevent pregnancy. The efficacy of Natazia in women with a body mass index (BMI) of > 30 kg/m 2 has not been evaluated. 1.2 Heavy Me…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50419-409

What is NDC 50419-409?: 50419-409 is the product NDC for Natazia 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?: Natazia (Estradiol valerate and estradiol valerate/dienogest).
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 Natazia?: 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 022252

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022252
Product	Strength	Form · route	Labeler	Product NDC
Estradiol Valerate and Estradiol Valerate/Dienogest	—	Kit	Sandoz Inc	0781-4110