NDC codes

FDA NDC Directory
Product NDC (as listed)71610-043Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0043Add 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
71610-043-60716100043607161000436090 TABLET in 1 BOTTLE (71610-043-60)Marketed from Mar 2, 2018

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)
Doxazosin
Generic name (nonproprietary)
doxazosin
Active ingredients
Doxazosin mesylate — 4 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075580
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)
Identifiers
Product ID 71610-043_98f8771c-b6c1-4fbe-845f-876cc3cbfe75SPL ID 98f8771c-b6c1-4fbe-845f-876cc3cbfe75SPL set ID 7e547752-a53a-4ad9-b70e-7cc2a1dd5d5dRxCUI 197627UNII 86P6PQK0MU
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

N471610004360 followed by a unit qualifier and the quantity

Package 71610-0043-60. 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)

INDICATIONS AND USAGE A. Benign Prostatic Hyperplasia (BPH). Doxazosin Tablets, USP are indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). Doxazosin Tablets, USP may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with Doxazosin Tablets, USP monotherapy. Doxazosin Tablets, USP provide rapid improvement in symptoms and urinary flow r…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-043

What is NDC 71610-043?
71610-043 is the product NDC for Doxazosin, Doxazosin mesylate 4 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Doxazosin.
What is the active ingredient?
Doxazosin mesylate.
Who is the labeler?
Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Doxazosin?
106 other product NDCs are listed under this name. See all Doxazosin 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 Doxazosin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DoxazosinDoxazosin mesylate 8 mg/1TabletOralRising Pharma Holdings, Inc.16571-16816571-0168-01
DoxazosinDoxazosin mesylate 1 mg/1TabletOralRising Pharma Holdings, Inc.16571-16516571-0165-01
DoxazosinDoxazosin mesylate 2 mg/1TabletOralRising Pharma Holdings, Inc.16571-16616571-0166-01
DoxazosinDoxazosin mesylate 4 mg/1TabletOralRising Pharma Holdings, Inc.16571-16716571-0167-01
Doxazosindoxazosin mesylateDoxazosin mesylate 2 mg/1TabletOralAurobindo Pharma Limited59651-89359651-0893-0159651-0893-99
Doxazosindoxazosin mesylateDoxazosin mesylate 1 mg/1TabletOralAurobindo Pharma Limited59651-89259651-0892-0159651-0892-99
Doxazosindoxazosin mesylateDoxazosin mesylate 4 mg/1TabletOralAurobindo Pharma Limited59651-89459651-0894-0159651-0894-99
Doxazosindoxazosin mesylateDoxazosin mesylate 8 mg/1TabletOralAurobindo Pharma Limited59651-89559651-0895-0159651-0895-99
DoxazosinDoxazosin mesylate 4 mg/1TabletOralREMEDYREPACK INC.70518-403170518-4031-00
DoxazosinDoxazosin mesylate 2 mg/1TabletOralREMEDYREPACK INC.70518-396570518-3965-0070518-3965-01

All 107 Doxazosin NDCs

Other NDCs under ANDA 075580

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

FDA NDC Directory listings under ANDA 075580
ProductStrengthForm · routeLabelerProduct NDC
DoxazosinDoxazosin mesylate 1 mg/1TabletOralMajor Pharmaceuticals0904-5522
DoxazosinDoxazosin mesylate 2 mg/1TabletOralMajor Pharmaceuticals0904-5523
DoxazosinDoxazosin mesylate 4 mg/1TabletOralMajor Pharmaceuticals0904-5524
DoxazosinDoxazosin mesylate 2 mg/1TabletOralAvKARE42291-258
DoxazosinDoxazosin mesylate 4 mg/1TabletOralAvKARE42291-259
DoxazosinDoxazosin mesylate 8 mg/1TabletOralAvKARE42291-260
DoxazosinDoxazosin mesylate 2 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-739
DoxazosinDoxazosin mesylate 1 mg/1TabletOralA-S Medication Solutions50090-0701
DoxazosinDoxazosin mesylate 2 mg/1TabletOralA-S Medication Solutions50090-0704
DoxazosinDoxazosin mesylate 1 mg/1TabletOralAvPAK50268-222
DoxazosinDoxazosin mesylate 2 mg/1TabletOralAvPAK50268-223
DoxazosinDoxazosin mesylate 4 mg/1TabletOralAvPAK50268-224
DoxazosinDoxazosin mesylate 8 mg/1TabletOralAvPAK50268-225
DoxazosinDoxazosin mesylate 1 mg/1TabletOralNorthwind Health Company, LLC51655-476
DoxazosinDoxazosin mesylate 2 mg/1TabletOralCardinal Health 107, LLC55154-7996
DoxazosinDoxazosin mesylate 1 mg/1TabletOralApotex Corp.60505-0093
DoxazosinDoxazosin mesylate 2 mg/1TabletOralApotex Corp.60505-0094
DoxazosinDoxazosin mesylate 4 mg/1TabletOralApotex Corp.60505-0095
DoxazosinDoxazosin mesylate 8 mg/1TabletOralApotex Corp.60505-0096
DoxazosinDoxazosin mesylate 4 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3298

Showing 20 of 33.

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