NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6177Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6177Add 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
50090-6177-1500906177015009061770190 TABLET, COATED in 1 BOTTLE (50090-6177-1)Marketed from Oct 18, 2022

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, Coated
Route
Oral
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211324
Marketing start
Listing expires
Other FDA classes
Selective Estrogen Receptor Modulators (Mechanism)
Identifiers
Product ID 50090-6177_88a25d54-f913-4a43-9f04-9ab1979ff633SPL ID 88a25d54-f913-4a43-9f04-9ab1979ff633SPL set ID 22a951ee-2ffc-4c60-b681-0f80285153e1RxCUI 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

N450090617701 followed by a unit qualifier and the quantity

Package 50090-6177-01. 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 is 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 is indicated for the tr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-6177

What is NDC 50090-6177?
50090-6177 is the product NDC for Raloxifene hydrochloride, Raloxifene hydrochloride 60 mg/1 tablet, coated, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Raloxifene hydrochloride.
What is the active ingredient?
Raloxifene hydrochloride.
Who is the labeler?
A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Raloxifene hydrochloride?
19 other product NDCs are listed under this name. See all Raloxifene hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Raloxifene hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Raloxifene HydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, Film coatedOralAvPAK50268-69450268-0694-15
Raloxifene hydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, CoatedOralCadila Pharmaceuticals Limited71209-08271209-0082-0171209-0082-0571209-0082-11+1 more
Raloxifene hydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, CoatedOralBryant Ranch Prepack72162-241872162-2418-0072162-2418-0172162-2418-03
Raloxifene hydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, CoatedOralModavar Pharmaceuticals LLC72241-01072241-0010-0572241-0010-1172241-0010-13+1 more
Raloxifene HydrochlorideraloxifeneRaloxifene hydrochloride 60 mg/1TabletOralAmerican Health Packaging60687-26660687-0266-21
Raloxifene hydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-690200904-6902-04
Raloxifene hydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, Film coatedOralDr.Reddys Laboratories Inc43598-50543598-0505-0143598-0505-1043598-0505-30
Raloxifene hydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals Inc50228-30650228-0306-2050228-0306-30
Raloxifene hydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-146071335-1460-0171335-1460-02
Raloxifene hydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-05371610-0053-60

All 20 Raloxifene hydrochloride NDCs

Other NDCs under ANDA 211324

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

FDA NDC Directory listings under ANDA 211324
ProductStrengthForm · routeLabelerProduct NDC
Raloxifene hydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, CoatedOralCadila Pharmaceuticals Limited71209-082
Raloxifene hydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, CoatedOralBryant Ranch Prepack72162-2418
Raloxifene hydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, CoatedOralModavar Pharmaceuticals LLC72241-010

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