NDC codes

FDA NDC Directory
Product NDC (as listed)0591-2472Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00591-2472Add 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
0591-2472-180059124721800591247218180 TABLET in 1 BOTTLE, PLASTIC (0591-2472-18)Marketed from Aug 15, 2011
0591-2472-60005912472600059124726060 TABLET in 1 BOTTLE, PLASTIC (0591-2472-60)Marketed from Aug 15, 2011

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)
Tamoxifen Citrate
Generic name (nonproprietary)
tamoxifen citrate
Active ingredients
Tamoxifen citrate — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Actavis Pharma, Inc.NDC labeler code 0591
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 070929
Marketing start
Listing expires
Other FDA classes
Selective Estrogen Receptor Modulators (Mechanism)
Identifiers
Product ID 0591-2472_20254a14-2e07-4279-8263-c63b6a71d861SPL ID 20254a14-2e07-4279-8263-c63b6a71d861SPL set ID 9b8a4211-120f-4981-ad69-928accb97637RxCUI 198240, 313195UNII 7FRV7310N6
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

N400591247218 followed by a unit qualifier and the quantity

Package 00591-2472-18. 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)

INDICATIONS AND USAGE Metastatic Breast Cancer: Tamoxifen citrate tablets, USP are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. Adjuvant Treatment of Breast Cancer: Tamoxifen citrate tablets, USP are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen adjuvant studies, most of the…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0591-2472

What is NDC 0591-2472?
0591-2472 is the product NDC for Tamoxifen Citrate, Tamoxifen citrate 10 mg/1 tablet, listed with the FDA by Actavis Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tamoxifen Citrate.
What is the active ingredient?
Tamoxifen citrate.
Who is the labeler?
Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tamoxifen Citrate?
16 other product NDCs are listed under this name. See all Tamoxifen Citrate 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 Tamoxifen Citrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tamoxifen CitrateTamoxifen citrate 10 mg/1Tablet, Film coatedOralDr. Reddy's Labratories Inc.75907-05875907-0058-1075907-0058-60
Tamoxifen CitrateTamoxifen citrate 20 mg/1Tablet, Film coatedOralDr. Reddy's Labratories Inc.75907-05975907-0059-1075907-0059-30
Tamoxifen CitrateTamoxifen citrate 20 mg/1Tablet, Film coatedOralMayne Pharma Commercial LLC51862-64351862-0643-1051862-0643-30
Tamoxifen CitrateTamoxifen citrate 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-29959651-0299-60
Tamoxifen CitrateTamoxifen citrate 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-30059651-0300-3059651-0300-90
Tamoxifen CitrateTamoxifen citrate 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-399068071-3990-03
Tamoxifen CitrateTamoxifen citrate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-220872162-2208-06
Tamoxifen CitrateTamoxifen citrate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-220972162-2209-03
Tamoxifen CitrateTamoxifen citrate 20 mg/1TabletOralActavis Pharma, Inc.0591-247300591-2473-1900591-2473-30
Tamoxifen CitrateTamoxifen citrate 10 mg/1TabletOralA-S Medication Solutions50090-048550090-0485-01

All 17 Tamoxifen Citrate NDCs

Other NDCs under ANDA 070929

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

FDA NDC Directory listings under ANDA 070929
ProductStrengthForm · routeLabelerProduct NDC
Tamoxifen CitrateTamoxifen citrate 20 mg/1TabletOralActavis Pharma, Inc.0591-2473
Tamoxifen CitrateTamoxifen citrate 10 mg/1TabletOralA-S Medication Solutions50090-0485
Tamoxifen CitrateTamoxifen citrate 20 mg/1TabletOralA-S Medication Solutions50090-0942
Tamoxifen CitrateTamoxifen citrate 20 mg/1TabletOralProficient Rx LP63187-976
Tamoxifen CitrateTamoxifen citrate 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5254
Tamoxifen CitrateTamoxifen citrate 10 mg/1TabletOralBryant Ranch Prepack72162-2225

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