Prescription drug · ANDA

Terazosin Hydrochloride NDC 71610-854

Terazosin hydrochloride 1 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)71610-854Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0854Add 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
71610-854-307161008543030 CAPSULE in 1 BOTTLE (71610-854-30)Marketed from Sep 3, 2024
71610-854-537161008545360 CAPSULE in 1 BOTTLE (71610-854-53)Marketed from Sep 3, 2024
71610-854-607161008546090 CAPSULE in 1 BOTTLE (71610-854-60)Marketed from Sep 3, 2024
71610-854-8071610085480180 CAPSULE in 1 BOTTLE (71610-854-80)Marketed from Sep 3, 2024

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)
Terazosin Hydrochloride
Generic name (nonproprietary)
terazosin hydrochloride
Active ingredients
Terazosin hydrochloride — 1 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074823
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)
Identifiers
Product ID 71610-854_214d9180-c434-330d-e063-6394a90a795cSPL ID 214d9180-c434-330d-e063-6394a90a795cSPL set ID 214d9b06-8d23-3ee8-e063-6394a90a1521RxCUI 313215UNII D32S14F082
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

N471610085430 followed by a unit qualifier and the quantity

Package 71610-0854-30. 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 Terazosin capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules, USP. The long-term effects of terazosin capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules, USP are also indicated for the treatment of hypertension. Terazosin capsules, USP can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074823

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

FDA NDC Directory listings under ANDA 074823
ProductStrengthForm · routeLabelerProduct NDC
Terazosin HydrochlorideTerazosin hydrochloride 1 mg/1CapsuleOralAmerisyn LLC87564-081
Terazosin HydrochlorideTerazosin hydrochloride 2 mg/1CapsuleOralAmerisyn, LLC87564-007
Terazosin HydrochlorideTerazosin hydrochloride 1 mg/1CapsuleOralAmerisyn, LLC87564-006
Terazosin HydrochlorideTerazosin hydrochloride 5 mg/1CapsuleOralAmerisyn, LLC87564-008
Terazosin HydrochlorideTerazosin hydrochloride 10 mg/1CapsuleOralAmerisyn, LLC87564-009
Terazosin HydrochlorideTerazosin hydrochloride 10 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-594
Terazosin HydrochlorideTerazosin hydrochloride 5 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-595
Terazosin HydrochlorideTerazosin hydrochloride 2 mg/1CapsuleOralAmerisyn LLC87564-082
Terazosin HydrochlorideTerazosin hydrochloride 5 mg/1CapsuleOralAmerisyn LLC87564-083
Terazosin HydrochlorideTerazosin hydrochloride 10 mg/1CapsuleOralAmerisyn LLC87564-084
Terazosin HydrochlorideTerazosin hydrochloride 1 mg/1CapsuleOralApnar Pharma LP24689-001
Terazosin HydrochlorideTerazosin hydrochloride 1 mg/1CapsuleOralAmici Pharma, Inc.69292-201
Terazosin HydrochlorideTerazosin hydrochloride 10 mg/1CapsuleOralApnar Pharma LP24689-004
Terazosin HydrochlorideTerazosin hydrochloride 2 mg/1CapsuleOralAmici Pharma, Inc.69292-202
Terazosin HydrochlorideTerazosin hydrochloride 2 mg/1CapsuleOralApnar Pharma LP24689-002
Terazosin HydrochlorideTerazosin hydrochloride 5 mg/1CapsuleOralAmici Pharma, Inc.69292-203
Terazosin HydrochlorideTerazosin hydrochloride 5 mg/1CapsuleOralApnar Pharma LP24689-003
Terazosin HydrochlorideTerazosin hydrochloride 10 mg/1CapsuleOralAmici Pharma, Inc.69292-204
Terazosin HydrochlorideTerazosin hydrochloride 2 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-698

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