NDC codes

FDA NDC Directory
Product NDC (as listed)57237-114Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57237-0114Add 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
57237-114-015723701140157237011401100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-01)Marketed from Aug 30, 2012
57237-114-055723701140557237011405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-05)Marketed from Aug 30, 2012
57237-114-90572370114905723701149090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-90)Marketed from Aug 30, 2012

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Alfuzosin Hydrochloride
Generic name (nonproprietary)
alfuzosin hydrochloride
Active ingredients
Alfuzosin hydrochloride — 10 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 57237
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079060
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)
Identifiers
Product ID 57237-114_c759b18f-8985-4b41-852f-2aa423b32748SPL ID c759b18f-8985-4b41-852f-2aa423b32748SPL set ID 43675e9d-a361-4109-9ae1-54d80580fbbdRxCUI 861132UNII 75046A1XTN
Pharmacologic class
alpha-Adrenergic Blocker

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

N457237011401 followed by a unit qualifier and the quantity

Package 57237-0114-01. 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 .

Indications (excerpt from the label)

Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets are an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1) Important Limitations of Use: Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. (1.1) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. (1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets are not indicated for the treatment of hypertension.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57237-114

What is NDC 57237-114?
57237-114 is the product NDC for Alfuzosin Hydrochloride, Alfuzosin hydrochloride 10 mg/1 tablet, film coated, extended release, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Alfuzosin Hydrochloride.
What is the active ingredient?
Alfuzosin hydrochloride.
Who is the labeler?
Rising Pharma Holdings, Inc., NDC labeler code 57237. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Alfuzosin Hydrochloride?
13 other product NDCs are listed under this name. See all Alfuzosin 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 Alfuzosin Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited84386-15384386-0153-0184386-0153-0584386-0153-30+2 more
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralApotex Corp.60505-285060505-2850-09
Alfuzosin hydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-96751655-0967-52
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralNorthwind Health Company, LLC51655-08751655-0087-52
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-43251655-0432-52
Alfuzosin hydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralUnichem Pharmaceuticals (USA), Inc.29300-15529300-0155-0129300-0155-1329300-0155-19
Alfuzosin hydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-915563629-9155-0163629-9155-0263629-9155-03+1 more
Alfuzosin hydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC43353-94543353-0945-1643353-0945-3043353-0945-60
Alfuzosin hydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Extended releaseOralExelan Pharmaceuticals Inc.76282-30276282-0302-0176282-0302-0576282-0302-10+2 more
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-257871335-2578-0171335-2578-0271335-2578-03+2 more

All 14 Alfuzosin Hydrochloride NDCs

Other NDCs under ANDA 079060

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

FDA NDC Directory listings under ANDA 079060
ProductStrengthForm · routeLabelerProduct NDC
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralNorthwind Health Company, LLC51655-087
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-2578
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited84386-153

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