Oshih NDC 59651-504

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-504Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0504Add 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
59651-504-88	59651050488	3 POUCH in 1 CARTON (59651-504-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Dec 6, 2023

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): Oshih
Generic name (nonproprietary): norethindrone acetate and ethinyl estradiol and ferrous fumarate
Dosage form: Kit
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216558
Marketing start: Dec 6, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 59651-504_3bf10185-1849-49a1-9b3b-ba35a0413408SPL ID 3bf10185-1849-49a1-9b3b-ba35a0413408SPL set ID 7c07e339-3aae-4c77-a170-e6715bbe7563RxCUI 259176, 1426288, 1426600

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

N459651050488 followed by a unit qualifier and the quantity

Package 59651-0504-88. 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 Feb 3, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Oshih is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14) ]. The efficacy of Oshih in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. Oshih is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy ( 1 ) The efficacy in females of reproductive potential with a body mass index of more than 35 kg/m 2 has not been evaluated ( 1 , 8.8 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)