Prescription drug · ANDA
Prazosin Hydrochloride NDC 68084-997
Prazosin hydrochloride 2 mg/1 · Capsule · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-997-01 | 68084099701 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-997-01) / 1 CAPSULE in 1 BLISTER PACK (68084-997-11)Marketed from May 11, 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)
- Prazosin Hydrochloride
- Generic name (nonproprietary)
- prazosin hydrochloride
- Active ingredients
- Prazosin hydrochloride — 2 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 68084
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071745
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 68084-997_2b32cc04-a4d4-2cdd-e063-6394a90a2c85SPL ID 2b32cc04-a4d4-2cdd-e063-6394a90a2c85SPL set ID 2b9f51fb-da48-4c81-b6b7-eb74b9cbaaf4RxCUI 312593, 312594UNII X0Z7454B90
- 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
N468084099701followed by a unit qualifier and the quantityPackage 68084-0997-01. 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)
INDICATIONS AND USAGE Prazosin hydrochloride capsules USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achie…
Excerpt only. Read the full label for complete information.
About NDC 68084-997
- What is NDC 68084-997?
- 68084-997 is the product NDC for Prazosin Hydrochloride, Prazosin hydrochloride 2 mg/1 capsule, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prazosin Hydrochloride.
- What is the active ingredient?
- Prazosin hydrochloride.
- Who is the labeler?
- American Health Packaging, NDC labeler code 68084. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prazosin Hydrochloride?
- 104 other product NDCs are listed under this name. See all Prazosin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prazosin Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| prazosin hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | Coupler LLC | 67046-1050 | 67046-1050-03 |
| prazosin hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4712 | 70518-4712-00 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-067 | 87441-0067-01 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-068 | 87441-0068-01 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | Coupler LLC | 67046-0781 | 67046-0781-03 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | Coupler LLC | 67046-1678 | 67046-1678-03 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Coupler LLC | 67046-0504 | 67046-0504-03 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Coupler LLC | 67046-0680 | 67046-0680-03 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Safecor Health LLC | 48433-084 | 48433-0084-20 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Safecor Health LLC | 48433-085 | 48433-0085-20 |
Other NDCs under ANDA 071745
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8750 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8756 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | Proficient Rx LP | 71205-585 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-8181 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | American Health Packaging | 60687-572 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7335 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3352 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-4067 |
| Prazosin Hydrochloride | Prazosin hydrochloride 2 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-4068 |
| Prazosin Hydrochloride | Prazosin hydrochloride 5 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-4069 |
| Prazosin Hydrochloride | Prazosin hydrochloride 1 mg/1 | CapsuleOral | American Health Packaging | 68084-996 |