NDC codes

FDA NDC Directory
Product NDC (as listed)0093-7290Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-7290Add 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
0093-7290-0100093729001100 TABLET, FILM COATED in 1 BOTTLE (0093-7290-01)Marketed from Mar 28, 2014
0093-7290-560009372905630 TABLET, FILM COATED in 1 BOTTLE (0093-7290-56)Marketed from Mar 28, 2014

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)
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 078193
Marketing start
Listing expires
Other FDA classes
Selective Estrogen Receptor Modulators (Mechanism)
Identifiers
Product ID 0093-7290_3641edbc-4bae-45d0-8afb-8db02f401f66SPL ID 3641edbc-4bae-45d0-8afb-8db02f401f66SPL set ID e6be5b1d-757d-4bab-ad6a-c421960a104dRxCUI 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

N400093729001 followed by a unit qualifier and the quantity

Package 00093-7290-01. 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 tablets are 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 table…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078193

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

FDA NDC Directory listings under ANDA 078193
ProductStrengthForm · routeLabelerProduct NDC
Raloxifene HydrochlorideRaloxifene hydrochloride 60 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1715

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