Prescription drug · ANDA
Tamsulosin Hydrochloride NDC 62135-775
Tamsulosin hydrochloride .4 mg/1 · Capsule · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-775-30 | 62135077530 | 30 CAPSULE in 1 BOTTLE (62135-775-30)Marketed from Nov 1, 2023 | |
| 62135-775-90 | 62135077590 | 90 CAPSULE in 1 BOTTLE (62135-775-90)Marketed from Sep 8, 2023 |
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
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207405
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 62135-775_45adcea0-c5c1-9431-e063-6294a90a0471SPL ID 45adcea0-c5c1-9431-e063-6294a90a0471SPL set ID 14db58df-7584-410b-8cf4-4b928dada859RxCUI 863669UNII 11SV1951MRUPC 0362135775308, 0362135775902
- 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
N462135077530followed by a unit qualifier and the quantityPackage 62135-0775-30. 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 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 207405
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 | Ascend Laboratories, LLC | 67877-450 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1538 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | AvPAK | 50268-740 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3646 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-4906 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Proficient Rx LP | 71205-217 |
| Tamsulosin Hydrochloride | Tamsulosin hydrochloride .4 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-879 |