Prescription drug · ANDA

Pramipexole Dihydrochloride NDC 33342-208

Pramipexole dihydrochloride .375 mg/1 · Tablet, Extended release · Oral · Macleods Pharmaceuticals Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)33342-208Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0208Add 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 NDC11-digit (billing)PackageCopy
33342-208-073334202080730 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-208-07)Marketed from Aug 24, 2020
33342-208-123334202081210 BLISTER PACK in 1 CARTON (33342-208-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 24, 2020

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 — .375 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206156
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 33342-208_4bae794e-6b1f-4630-9d00-a4524fffa0b9SPL ID 4bae794e-6b1f-4630-9d00-a4524fffa0b9SPL set ID 1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7beRxCUI 901534, 901541, 901546, 901550, 901555, 1114479, 1114485UNII 3D867NP06JUPC 0333342209078, 0333342214072, 0333342212122, 0333342210074, 0333342208071, 0333342211071, 0333342213075
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

N433342020807 followed by a unit qualifier and the quantity

Package 33342-0208-07. 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 tablets are 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 206156

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

FDA NDC Directory listings under ANDA 206156
ProductStrengthForm · routeLabelerProduct NDC
Pramipexole DihydrochloridePramipexole dihydrochloride .375 mg/1Tablet, Extended releaseOralNorthStar RxLLC16714-916
Pramipexole DihydrochloridePramipexole dihydrochloride 3 mg/1Tablet, Extended releaseOralNorthStar RxLLC16714-920
Pramipexole DihydrochloridePramipexole dihydrochloride .75 mg/1Tablet, Extended releaseOralNorthStar RxLLC16714-917
Pramipexole DihydrochloridePramipexole dihydrochloride 1.5 mg/1Tablet, Extended releaseOralNorthStar RxLLC16714-918
Pramipexole DihydrochloridePramipexole dihydrochloride 2.25 mg/1Tablet, Extended releaseOralNorthStar RxLLC16714-919
Pramipexole DihydrochloridePramipexole dihydrochloride 4.5 mg/1Tablet, Extended releaseOralNorthStar RxLLC16714-922
Pramipexole DihydrochloridePramipexole dihydrochloride 3 mg/1Tablet, Extended releaseOralMacleods Pharmaceuticals Limited33342-212
Pramipexole DihydrochloridePramipexole dihydrochloride .75 mg/1Tablet, Extended releaseOralMacleods Pharmaceuticals Limited33342-209
Pramipexole DihydrochloridePramipexole dihydrochloride 1.5 mg/1Tablet, Extended releaseOralMacleods Pharmaceuticals Limited33342-210
Pramipexole DihydrochloridePramipexole dihydrochloride 2.25 mg/1Tablet, Extended releaseOralMacleods Pharmaceuticals Limited33342-211
Pramipexole DihydrochloridePramipexole dihydrochloride 3.75 mg/1Tablet, Extended releaseOralMacleods Pharmaceuticals Limited33342-213
Pramipexole DihydrochloridePramipexole dihydrochloride 4.5 mg/1Tablet, Extended releaseOralMacleods Pharmaceuticals Limited33342-214

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in
Pramipexole Dihydrochloride NDC 33342-208 | Med-Code