Pramipexole dihydrochloride NDC 33342-033

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-033Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0033Add 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
33342-033-06	33342003306	30 BLISTER PACK in 1 CARTON (33342-033-06) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 21, 2012
33342-033-10	33342003310	90 TABLET in 1 BOTTLE (33342-033-10)Marketed from Sep 21, 2012
33342-033-12	33342003312	100 BLISTER PACK in 1 CARTON (33342-033-12) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 21, 2012
33342-033-15	33342003315	500 TABLET in 1 BOTTLE (33342-033-15)Marketed from Sep 21, 2012

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 — .5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202164
Marketing start: Sep 21, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Dopamine Agonists (Mechanism)
Identifiers: Product ID 33342-033_721c81fc-fd21-4d86-ab96-9a329b8e015bSPL ID 721c81fc-fd21-4d86-ab96-9a329b8e015bSPL set ID b8c94917-73a1-44c2-8fd8-07f45054176bRxCUI 859033, 859040, 859044, 859048, 859052UNII 3D867NP06JUPC 0333342031105, 0333342035103, 0333342034106, 0333342033109, 0333342032102
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

N433342003306 followed by a unit qualifier and the quantity

Package 33342-0033-06. 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 Oct 15, 2025.

Indications (excerpt from the label)

Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of: · Parkinson’s disease (PD) ( 1.1 ) • Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2 ) 1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202164

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

FDA NDC Directory listings under ANDA 202164
Product	Strength	Form · route	Labeler	Product NDC
Pramipexole dihydrochloride	Pramipexole dihydrochloride .125 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-031
Pramipexole dihydrochloride	Pramipexole dihydrochloride .25 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-032
Pramipexole dihydrochloride	Pramipexole dihydrochloride 1 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-034
Pramipexole dihydrochloride	Pramipexole dihydrochloride 1.5 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-035