Prescription drug · ANDA

Pramipexole Dihydrochloride NDC 33342-211

Pramipexole dihydrochloride 2.25 mg/1 · Tablet, Extended release · Oral · Macleods Pharmaceuticals Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)33342-211Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0211Add 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
33342-211-073334202110730 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-211-07)Marketed from Aug 24, 2020
33342-211-123334202111210 BLISTER PACK in 1 CARTON (33342-211-12) / 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 — 2.25 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Macleods Pharmaceuticals LimitedNDC labeler code 33342
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 33342-211_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

N433342021107 followed by a unit qualifier and the quantity

Package 33342-0211-07. 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)

About NDC 33342-211

What is NDC 33342-211?
33342-211 is the product NDC for Pramipexole Dihydrochloride, Pramipexole dihydrochloride 2.25 mg/1 tablet, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, 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?
Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pramipexole Dihydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pramipexole dihydrochloridePramipexole dihydrochloride 1.5 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-33350742-0333-30
Pramipexole dihydrochloridePramipexole dihydrochloride .375 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-33150742-0331-30
Pramipexole dihydrochloridePramipexole dihydrochloride .75 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-33250742-0332-30
Pramipexole dihydrochloridePramipexole dihydrochloride 4.5 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-33750742-0337-30
Pramipexole dihydrochloridePramipexole dihydrochloride 2.25 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-33450742-0334-30
Pramipexole dihydrochloridePramipexole dihydrochloride 3 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-33550742-0335-30
Pramipexole dihydrochloridePramipexole dihydrochloride 3.75 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-33650742-0336-30
Pramipexole DihydrochloridePramipexole dihydrochloride .75 mg/1Tablet, Extended releaseOralVitruvias Therapeutics, Inc.69680-14669680-0146-30
pramipexole dihydrochloridePramipexole dihydrochloride .25 mg/1TabletOralStrides Pharma Science Limited64380-74764380-0747-0164380-0747-05
pramipexole dihydrochloridePramipexole dihydrochloride .125 mg/1TabletOralStrides Pharma Science Limited64380-74664380-0746-05

All 128 Pramipexole Dihydrochloride NDCs

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 .75 mg/1Tablet, Extended releaseOralMacleods Pharmaceuticals Limited33342-209
Pramipexole DihydrochloridePramipexole dihydrochloride .375 mg/1Tablet, Extended releaseOralMacleods Pharmaceuticals Limited33342-208
Pramipexole DihydrochloridePramipexole dihydrochloride 3.75 mg/1Tablet, Extended releaseOralMacleods Pharmaceuticals Limited33342-213
Pramipexole DihydrochloridePramipexole dihydrochloride 1.5 mg/1Tablet, Extended releaseOralMacleods Pharmaceuticals Limited33342-210
Pramipexole DihydrochloridePramipexole dihydrochloride 3 mg/1Tablet, Extended releaseOralMacleods Pharmaceuticals Limited33342-212
Pramipexole DihydrochloridePramipexole dihydrochloride 4.5 mg/1Tablet, Extended releaseOralMacleods Pharmaceuticals Limited33342-214

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Pramipexole Dihydrochloride NDC 33342-211 | Med-Code