Pramipexole dihydrochloride NDC 55111-613

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-613Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0613Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
55111-613-30	55111061330	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-613-30)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 — 1.5 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Dr. Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203354
Marketing start: Aug 14, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Dopamine Agonists (Mechanism)
Identifiers: Product ID 55111-613_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

N455111061330 followed by a unit qualifier and the quantity

Package 55111-0613-30. 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 Aug 31, 2021.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203354

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203354
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 3 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Limited	55111-614
Pramipexole dihydrochloride	Pramipexole dihydrochloride 4.5 mg/1	Tablet, Extended releaseOral	Dr. Reddy's Laboratories Limited	55111-615