Prescription drug · ANDA
Tamsulosin Hydrochloride NDC 68084-299
Tamsulosin hydrochloride .4 mg/1 · Capsule · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-299-01 | 68084029901 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-299-01) / 1 CAPSULE in 1 BLISTER PACK (68084-299-11)Marketed from Jan 17, 2014 | |
| 68084-299-65 | 68084029965 | 50 BLISTER PACK in 1 CARTON (68084-299-65) / 1 CAPSULE in 1 BLISTER PACK (68084-299-11)Marketed from Jul 1, 2025 |
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)
- Tamsulosin Hydrochloride
- Generic name (nonproprietary)
- tamsulosin hydrochloride
- Active ingredients
- Tamsulosin hydrochloride — .4 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- American Health Packaging
- 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 68084-299_38cbc0fa-ca6b-0e39-e063-6394a90abb97SPL ID 38cbc0fa-ca6b-0e39-e063-6394a90abb97SPL set ID 8150a710-aee5-4841-ae1b-7d2e61281a8fRxCUI 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
N468084029901followed by a unit qualifier and the quantityPackage 68084-0299-01. 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)
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. 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 )
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 | Bryant Ranch Prepack | 63629-4346 |
| 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 |