Prescription drug · ANDA
Tamsulosin Hydrochloride NDC 33342-159
Tamsulosin hydrochloride .4 mg/1 · Capsule · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-159-07 | 33342015907 | 30 CAPSULE in 1 BOTTLE (33342-159-07)Marketed from Jan 25, 2017 | |
| 33342-159-11 | 33342015911 | 100 CAPSULE in 1 BOTTLE (33342-159-11)Marketed from Jan 25, 2017 | |
| 33342-159-12 | 33342015912 | 10 BLISTER PACK in 1 CARTON (33342-159-12) / 10 CAPSULE in 1 BLISTER PACKMarketed from Jan 25, 2017 | |
| 33342-159-15 | 33342015915 | 500 CAPSULE in 1 BOTTLE (33342-159-15)Marketed from Jan 25, 2017 | |
| 33342-159-44 | 33342015944 | 1000 CAPSULE in 1 BOTTLE (33342-159-44)Marketed from Jan 25, 2017 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204645
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 33342-159_95b0ff14-97b3-4b8c-8545-f066a45c2f82SPL ID 95b0ff14-97b3-4b8c-8545-f066a45c2f82SPL set ID 2912fbbc-89bf-4bf0-86fe-bd98f3168e84RxCUI 863669UNII 11SV1951MRUPC 0333342159106, 0333342159113
- 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
N433342015907followed by a unit qualifier and the quantityPackage 33342-0159-07. 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 is 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 204645
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 | Bryant Ranch Prepack | 72162-2502 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4872 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-1840 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.