Prescription drug · ANDA
Dutasteride and tamsulosin hydrochloride NDC 70771-1356
Dutasteride .5 mg/1; Tamsulosin hydrochloride .4 mg/1 · Capsule · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1356-3 | 7077113560370771135603 | 30 CAPSULE in 1 BOTTLE (70771-1356-3)Marketed from Jun 4, 2018 | |
| 70771-1356-9 | 7077113560970771135609 | 90 CAPSULE in 1 BOTTLE (70771-1356-9)Marketed from Jun 4, 2018 |
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)
- Dutasteride and tamsulosin hydrochloride
- Generic name (nonproprietary)
- dutasteride and tamsulosin hydrochloride
- Active ingredients
- Dutasteride — .5 mg/1Tamsulosin hydrochloride — .4 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207769
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 70771-1356_cdb5801c-8313-41cc-908e-24441940f578SPL ID cdb5801c-8313-41cc-908e-24441940f578
- Pharmacologic class
- 5-alpha Reductase Inhibitor; 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
N470771135603followed by a unit qualifier and the quantityPackage 70771-1356-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70771-1356
- What is NDC 70771-1356?
- 70771-1356 is the product NDC for Dutasteride and tamsulosin hydrochloride, Dutasteride .5 mg/1; Tamsulosin hydrochloride .4 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dutasteride and tamsulosin hydrochloride.
- What is the active ingredient?
- Dutasteride, Tamsulosin hydrochloride.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dutasteride and tamsulosin hydrochloride?
- 2 other product NDCs are listed under this name. See all Dutasteride and 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 Dutasteride and 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) |
|---|---|---|---|---|---|
| Dutasteride and Tamsulosin Hydrochloride | Dutasteride .5 mg/1; Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-063 | 59651-0063-3059651-0063-90 |
| Dutasteride and tamsulosin hydrochloride | Dutasteride .5 mg/1; Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 68382-640 | 68382-0640-0668382-0640-16 |
Other NDCs under ANDA 207769
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 |
|---|---|---|---|---|
| Dutasteride and tamsulosin hydrochloride | Dutasteride .5 mg/1; Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 68382-640 |