NDC codes

FDA NDC Directory
Product NDC (as listed)50090-7073Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-7073Add 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
50090-7073-15009070730190 TABLET, FILM COATED in 1 BOTTLE (50090-7073-1)Marketed from Jan 23, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204310
Marketing start
Listing expires
Other FDA classes
Selective Estrogen Receptor Modulators (Mechanism)
Identifiers
Product ID 50090-7073_c6ae957a-83c9-442d-89b2-9febb63c82d4SPL ID c6ae957a-83c9-442d-89b2-9febb63c82d4SPL set ID 804e873e-f48b-4c25-ad7b-41d44f61bddeRxCUI 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

N450090707301 followed by a unit qualifier and the quantity

Package 50090-7073-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Raloxifene hydrochloride is an estrogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. ( 1.1 ) Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. ( 1.2 ) Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. ( 1.3 ) Important Limitations: Raloxifene hydrochloride tablets are not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. ( 1.3 ) 1.1 Treatment and Prevention of Osteoporosis in Postmenopausal Women Raloxifene hydrochloride tablets are in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204310

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

FDA NDC Directory listings under ANDA 204310
ProductStrengthForm · routeLabelerProduct NDC
Raloxifene HydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-709
Raloxifene HydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-213
Raloxifene HydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2059

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in