What is NDC 0781-4110?

0781-4110 is the product NDC for Estradiol Valerate and Estradiol Valerate/Dienogest kit, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Estradiol Valerate and Estradiol Valerate/Dienogest?

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.

NDC 0781-4110

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-4110Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-4110Add 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	Copy
0781-4110-15	00781411015	3 BLISTER PACK in 1 PACKAGE (0781-4110-15) / 1 KIT in 1 BLISTER PACK (0781-4110-52)Marketed from Jan 21, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Estradiol Valerate and Estradiol Valerate/Dienogest
Generic name (nonproprietary): estradiol valerate and estradiol valerate/dienogest
Dosage form: Kit
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 022252
Marketing start: Aug 5, 2015
Listing expires: Dec 31, 2026
Identifiers: Product ID 0781-4110_ce80046e-2aca-4c57-af85-d985e3ae769fSPL ID ce80046e-2aca-4c57-af85-d985e3ae769fSPL set ID 0c3ac139-af85-4c70-ad3d-981e57d86f02RxCUI 748797, 978941, 978944, 978946, 978948, 978949

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

N400781411015 followed by a unit qualifier and the quantity

Package 00781-4110-15. 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 Jan 21, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-4110

What is NDC 0781-4110?: 0781-4110 is the product NDC for Estradiol Valerate and Estradiol Valerate/Dienogest kit, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Estradiol Valerate and Estradiol Valerate/Dienogest.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Estradiol Valerate and Estradiol Valerate/Dienogest?: 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
Nataziaestradiol valerate and estradiol valerate/dienogest	—	Kit	Bayer HealthCare Pharmaceuticals Inc.	50419-409

Estradiol Valerate and Estradiol Valerate/Dienogest NDC 0781-4110