Prescription drug · ANDA
Raloxifene Hydrochloride NDC 0093-7290
Raloxifene hydrochloride 60 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-7290-01 | 00093729001 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-7290-01)Marketed from Mar 28, 2014 | |
| 0093-7290-56 | 00093729056 | 30 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
N400093729001followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 078193
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Raloxifene Hydrochloride | Raloxifene hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1715 |