Prescription drug · ANDA
Pramipexole dihydrochloride NDC 55111-615
Pramipexole dihydrochloride 4.5 mg/1 · Tablet, Extended release · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-615-30 | 5511106153055111061530 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-615-30)Marketed from Aug 14, 2015 |
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)
- Pramipexole dihydrochloride
- Generic name (nonproprietary)
- pramipexole dihydrochloride
- Active ingredients
- Pramipexole dihydrochloride — 4.5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203354
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 55111-615_4dfe5cc9-1281-c6dc-a6dc-6113fd0aed67SPL ID 4dfe5cc9-1281-c6dc-a6dc-6113fd0aed67SPL set ID 00699692-532a-68fd-8a51-3770a81b2208RxCUI 901534, 901541, 901546, 901550, 901555UNII 3D867NP06J
- Pharmacologic class
- Nonergot Dopamine Agonist
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
N455111061530followed by a unit qualifier and the quantityPackage 55111-0615-30. 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)
Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease. Pramipexole dihydrochloride extended-release tablet is a non-ergot dopamine agonist indicated for the treatment of Parkinson’s disease (PD) (1)
Excerpt only. Read the full label for complete information.
About NDC 55111-615
- What is NDC 55111-615?
- 55111-615 is the product NDC for Pramipexole dihydrochloride, Pramipexole dihydrochloride 4.5 mg/1 tablet, extended release, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pramipexole dihydrochloride.
- What is the active ingredient?
- Pramipexole dihydrochloride.
- Who is the labeler?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pramipexole dihydrochloride?
- 127 other product NDCs are listed under this name. See all Pramipexole dihydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pramipexole dihydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pramipexole dihydrochloride | Pramipexole dihydrochloride .375 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-331 | 50742-0331-30 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 2.25 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-334 | 50742-0334-30 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-332 | 50742-0332-30 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-333 | 50742-0333-30 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 3 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-335 | 50742-0335-30 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 3.75 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-336 | 50742-0336-30 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 4.5 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-337 | 50742-0337-30 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | Tablet, Extended releaseOral | Vitruvias Therapeutics, Inc. | 69680-146 | 69680-0146-30 |
| pramipexole dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-746 | 64380-0746-05 |
| pramipexole dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-750 | 64380-0750-0164380-0750-05 |
Other NDCs under ANDA 203354
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 |
|---|---|---|---|---|
| Pramipexole dihydrochloride | Pramipexole dihydrochloride .375 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Limited | 55111-611 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Limited | 55111-612 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Limited | 55111-613 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 3 mg/1 | Tablet, Extended releaseOral | Dr. Reddy's Laboratories Limited | 55111-614 |