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 NDC11-digit (billing)PackageCopy
0480-3475-1600480347516004803475166 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.NDC labeler code 0480
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 017060
Marketing start
Listing expires
Other FDA classes
Progesterone Congeners (Chemical structure)
Identifiers
Product ID 0480-3475_78fd3447-1830-42be-9ebf-7555ad7ec5b6SPL ID 78fd3447-1830-42be-9ebf-7555ad7ec5b6
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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0480-3475

What is NDC 0480-3475?
0480-3475 is the product NDC for Nora BE (norethindrone), Norethindrone .35 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nora BE (Norethindrone).
What is the active ingredient?
Norethindrone.
Who is the labeler?
Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nora BE?
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.

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