Prescription drug · ANDA
Tamsulosin hydrochloride NDC 63672-0021
Tamsulosin hydrochloride .4 mg/1 · Capsule · Oral · Synthon Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63672-0021-9 | 6367200210963672002109 | 20000 CAPSULE in 1 DRUM (63672-0021-9)Marketed from Jan 15, 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
- Synthon Pharmaceuticals, Inc.NDC labeler code 63672
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078801
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 63672-0021_44e3098a-c374-d7aa-e063-6294a90aef5dSPL ID 44e3098a-c374-d7aa-e063-6294a90aef5dSPL set ID 13a5032d-0be1-4001-916e-459f0b1a051dRxCUI 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
N463672002109followed by a unit qualifier and the quantityPackage 63672-0021-09. 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 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.
About NDC 63672-0021
- What is NDC 63672-0021?
- 63672-0021 is the product NDC for Tamsulosin hydrochloride, Tamsulosin hydrochloride .4 mg/1 capsule, listed with the FDA by Synthon Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tamsulosin hydrochloride.
- What is the active ingredient?
- Tamsulosin hydrochloride.
- Who is the labeler?
- Synthon Pharmaceuticals, Inc., NDC labeler code 63672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tamsulosin hydrochloride?
- 61 other product NDCs are listed under this name. See all Tamsulosin hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tamsulosin 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) |
|---|---|---|---|---|---|
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4145 | 68788-4145-0168788-4145-0368788-4145-06+2 more |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Coupler LLC | 67046-1015 | 67046-1015-03 |
| tamsulosin hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | XLCare Pharmaceuticals, Inc. | 72865-350 | 72865-0350-0572865-0350-90 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | AvKARE | 42291-989 | 42291-0989-1042291-0989-90 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 0115-8211 | 00115-8211-01 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-2142 | 55154-2142-00 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-2636 | 55154-2636-00 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | XLCare Pharmaceuticals, Inc | 72865-282 | 72865-0282-0172865-0282-0572865-0282-90 |
| Tamsulosin hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-910 | 71610-0910-3071610-0910-5371610-0910-60+2 more |
| Tamsulosin hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS, INC. | 76282-744 | 76282-0744-0576282-0744-90 |
Other NDCs under ANDA 078801
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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-910 |
| Tamsulosin hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS, INC. | 76282-744 |