Prescription drug · ANDA
Tamsulosin Hydrochloride NDC 63629-4346
Tamsulosin hydrochloride .4 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-4346-0 | 63629434600 | 3 CAPSULE in 1 BOTTLE (63629-4346-0)Marketed from Mar 8, 2024 | |
| 63629-4346-1 | 63629434601 | 30 CAPSULE in 1 BOTTLE (63629-4346-1)Marketed from Mar 8, 2024 | |
| 63629-4346-2 | 63629434602 | 100 CAPSULE in 1 BOTTLE (63629-4346-2)Marketed from Mar 8, 2024 | |
| 63629-4346-3 | 63629434603 | 60 CAPSULE in 1 BOTTLE (63629-4346-3)Marketed from Mar 8, 2024 | |
| 63629-4346-4 | 63629434604 | 10 CAPSULE in 1 BOTTLE (63629-4346-4)Marketed from Mar 8, 2024 | |
| 63629-4346-5 | 63629434605 | 90 CAPSULE in 1 BOTTLE (63629-4346-5)Marketed from Mar 8, 2024 | |
| 63629-4346-6 | 63629434606 | 180 CAPSULE in 1 BOTTLE (63629-4346-6)Marketed from Mar 8, 2024 | |
| 63629-4346-7 | 63629434607 | 7 CAPSULE in 1 BOTTLE (63629-4346-7)Marketed from Mar 8, 2024 | |
| 63629-4346-8 | 63629434608 | 15 CAPSULE in 1 BOTTLE (63629-4346-8)Marketed from Mar 8, 2024 | |
| 63629-4346-9 | 63629434609 | 120 CAPSULE in 1 BOTTLE (63629-4346-9)Marketed from Mar 8, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Tamsulosin Hydrochloride
- Generic name (nonproprietary)
- tamsulosin hydrochloride
- Active ingredients
- Tamsulosin hydrochloride — .4 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078225
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 63629-4346_8ae1167e-1178-49ea-bdd3-24a4689327c5SPL ID 8ae1167e-1178-49ea-bdd3-24a4689327c5SPL set ID e9372720-bd02-e4a6-0afd-42fe0c661c00RxCUI 863669UNII 11SV1951MR
- 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
N463629434600followed by a unit qualifier and the quantityPackage 63629-4346-00. 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)
Tamsulosin hydrochloride capsules are an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia ( 1 ) Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension ( 1 ) Tamsulosin hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies ( 14 )] . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078225
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 |
|---|---|---|---|---|
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 65841-695 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | American Health Packaging | 68084-299 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 68382-132 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Coupler LLC | 67046-1015 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-2142 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4145 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-724 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Quallent Pharmaceuticals Health LLC | 82009-025 |