What is NDC 51862-258?

51862-258 is the product NDC for Nextstellis kit, listed with the FDA by Mayne Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Nextstellis (Drospirenone and estetrol).

Mayne Pharma, NDC labeler code 51862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nextstellis?

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.

Nextstellis NDC 51862-258 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51862-258Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51862-0258Add 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
51862-258-00	51862025800	1 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)Marketed from Apr 16, 2021 · Sample package
51862-258-01	51862025801	1 BLISTER PACK in 1 CARTON (51862-258-01) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)Marketed from Apr 16, 2021

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): Nextstellis
Generic name (nonproprietary): drospirenone and estetrol
Dosage form: Kit
Labeler: Mayne PharmaNDC labeler code 51862
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 214154
Marketing start: Apr 16, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 51862-258_cb3d0738-1ec9-47a9-9167-8a4eb905ddabSPL ID cb3d0738-1ec9-47a9-9167-8a4eb905ddabSPL set ID c5270073-d083-4109-ae4b-156986175e0aRxCUI 748797, 2539032, 2539033, 2539036

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

N451862025800 followed by a unit qualifier and the quantity

Package 51862-0258-00. 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 May 11, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

NEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy. NEXTSTELLIS is a combination of drospirenone, a progestin, and estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Use NEXTSTELLIS may be less effective in females with a BMI ≥ 30 kg/m 2 . In females with BMI ≥ 30 kg/m 2 , decreasing effectiveness may be associated with increasing BMI ( 14 ). Limitations of Use NEXTSTELLIS may be less effective in females with a BMI ≥ 30 kg/m 2 . In females with BMI ≥ 30 kg/m 2 , decreasing effectiveness may be associated with increasing BMI [see Clinical Studies (14) ].

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51862-258

What is NDC 51862-258?: 51862-258 is the product NDC for Nextstellis kit, listed with the FDA by Mayne Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nextstellis (Drospirenone and estetrol).
Who is the labeler?: Mayne Pharma, NDC labeler code 51862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nextstellis?: 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.

Nextstellis (Drospirenone and estetrol) NDC 51862-258