Prescription drug · NDA AUTHORIZED GENERIC
Nora BE (Norethindrone) NDC 0480-3475
Norethindrone .35 mg/1 · Tablet · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-3475-16 | 0048034751600480347516 | 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.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
N400480347516followed by a unit qualifier and the quantityPackage 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.