Raloxifene Hydrochloride NDC 50268-694

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-694Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0694Add 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
50268-694-15	50268069415	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-694-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-694-11)Marketed from Jun 27, 2018

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): Raloxifene Hydrochloride
Generic name (nonproprietary): raloxifene hydrochloride
Active ingredients: Raloxifene hydrochloride — 60 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvPAK
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208206
Marketing start: Jun 27, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 50268-694_48255cf3-7607-03f0-e063-6394a90ae486SPL ID 48255cf3-7607-03f0-e063-6394a90ae486SPL set ID 6f7eb934-aa60-51e1-e053-2a91aa0a3914RxCUI 1490065UNII 4F86W47BR6
Pharmacologic class: Estrogen Agonist/Antagonist

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

N450268069415 followed by a unit qualifier and the quantity

Package 50268-0694-15. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 208206

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208206
Product	Strength	Form · route	Labeler	Product NDC
Raloxifene Hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-057