NDC codes

FDA NDC Directory
Product NDC (as listed)50742-337Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50742-0337Add 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
50742-337-30507420337305074203373030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-337-30)Marketed from Mar 10, 2022

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
Ingenus Pharmaceuticals, LLCNDC labeler code 50742
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213444
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 50742-337_74c3457e-079c-4b2b-bae4-3f148540a27aSPL ID 74c3457e-079c-4b2b-bae4-3f148540a27aSPL set ID 1d2b1d2c-ae22-424a-bad7-ce24a817b042RxCUI 901534, 901541, 901546, 901550, 901555, 1114479, 1114485UNII 3D867NP06JUPC 0350742337309, 0350742336302, 0350742334308, 0350742335305
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

N450742033730 followed by a unit qualifier and the quantity

Package 50742-0337-30. 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 tablet is a non-ergot dopamine agonist indicated for the treatment of Parkinson's disease (PD) ( 1 ) Pramipexole dihydrochloride extended- release tablets are indicated for the treatment of Parkinson's disease.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50742-337

What is NDC 50742-337?
50742-337 is the product NDC for Pramipexole dihydrochloride, Pramipexole dihydrochloride 4.5 mg/1 tablet, extended release, listed with the FDA by Ingenus Pharmaceuticals, LLC. 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?
Ingenus Pharmaceuticals, LLC, NDC labeler code 50742. 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 .375 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-33150742-0331-30
Pramipexole dihydrochloridePramipexole dihydrochloride 2.25 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-33450742-0334-30
Pramipexole dihydrochloridePramipexole dihydrochloride .75 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-33250742-0332-30
Pramipexole dihydrochloridePramipexole dihydrochloride 1.5 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-33350742-0333-30
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 .125 mg/1TabletOralStrides Pharma Science Limited64380-74664380-0746-05
pramipexole dihydrochloridePramipexole dihydrochloride 1 mg/1TabletOralStrides Pharma Science Limited64380-75064380-0750-0164380-0750-05
pramipexole dihydrochloridePramipexole dihydrochloride .25 mg/1TabletOralStrides Pharma Science Limited64380-74764380-0747-0164380-0747-05

All 128 Pramipexole dihydrochloride NDCs

Other NDCs under ANDA 213444

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

FDA NDC Directory listings under ANDA 213444
ProductStrengthForm · routeLabelerProduct NDC
Pramipexole dihydrochloridePramipexole dihydrochloride .375 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-331
Pramipexole dihydrochloridePramipexole dihydrochloride .75 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-332
Pramipexole dihydrochloridePramipexole dihydrochloride 1.5 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-333
Pramipexole dihydrochloridePramipexole dihydrochloride 2.25 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-334
Pramipexole dihydrochloridePramipexole dihydrochloride 3 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-335
Pramipexole dihydrochloridePramipexole dihydrochloride 3.75 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-336

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