What is NDC 69097-844?

69097-844 is the product NDC for Alfuzosin Hydrochloride extended release, Alfuzosin hydrochloride 10 mg/1 tablet, listed with the FDA by Cipla USA Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Alfuzosin Hydrochloride extended release (Alfuzosin Hydrochloride).

Cipla USA Inc., NDC labeler code 69097. 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 extended release?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Alfuzosin Hydrochloride extended release NDC 69097-844

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-844Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0844Add 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 NDC	11-digit (billing)	Package
69097-844-02	69097084402	30 TABLET in 1 BOTTLE (69097-844-02)Marketed from Jun 30, 2016
69097-844-05	69097084405	90 TABLET in 1 BOTTLE (69097-844-05)Marketed from Jun 30, 2016
69097-844-07	69097084407	100 TABLET in 1 BOTTLE (69097-844-07)Marketed from Jun 30, 2016
69097-844-12	69097084412	500 TABLET in 1 BOTTLE (69097-844-12)Marketed from Jun 30, 2016

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 extended releaseSuffix: extended release
Generic name (nonproprietary): alfuzosin hydrochloride
Active ingredients: Alfuzosin hydrochloride — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090284
Marketing start: Jun 30, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha-Antagonists (Mechanism)
Identifiers: Product ID 69097-844_497e0a60-9b09-4dcc-8cc6-1f13196f2db4SPL ID 497e0a60-9b09-4dcc-8cc6-1f13196f2db4SPL set ID 3cc028d5-309f-4ce3-a2d7-5804ab57677dRxCUI 861132UNII 75046A1XTNUPC 0369097844073
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

N469097084402 followed by a unit qualifier and the quantity

Package 69097-0844-02. 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 Oct 1, 2020.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-844

What is NDC 69097-844?: 69097-844 is the product NDC for Alfuzosin Hydrochloride extended release, Alfuzosin hydrochloride 10 mg/1 tablet, listed with the FDA by Cipla USA Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Alfuzosin Hydrochloride extended release (Alfuzosin Hydrochloride).
What is the active ingredient?: Alfuzosin hydrochloride.
Who is the labeler?: Cipla USA Inc., NDC labeler code 69097. 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 extended release?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 090284

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

FDA NDC Directory listings under ANDA 090284
Product	Strength	Form · route	Labeler	Product NDC
Alfuzosin hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	43353-945
Alfuzosin hydrochloride	Alfuzosin hydrochloride 10 mg/1	Tablet, Extended releaseOral	Exelan Pharmaceuticals Inc.	76282-302

Alfuzosin Hydrochloride extended release (Alfuzosin hydrochloride) NDC 69097-844