Nora BE (norethindrone) NDC 0480-3475

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-3475Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-3475Add 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
0480-3475-16	00480347516	6 PACKAGE in 1 CARTON (0480-3475-16) / 28 TABLET in 1 PACKAGEMarketed from Dec 1, 2023

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): Nora BE
Generic name (nonproprietary): norethindrone
Active ingredients: Norethindrone — .35 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Teva Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 017060
Marketing start: Dec 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Progesterone Congeners (Chemical structure)
Identifiers: Product ID 0480-3475_3f6f53f3-b61a-45d9-94ed-d2946a17212eSPL ID 3f6f53f3-b61a-45d9-94ed-d2946a17212eSPL set ID 426ac898-7745-4645-bf9b-bae319e260e8RxCUI 198042, 748961, 748977UNII T18F433X4S
Pharmacologic class: Progestin

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400480347516 followed by a unit qualifier and the quantity

Package 00480-3475-16. 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 Apr 2, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE 1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)