NDC codes

FDA NDC Directory
Product NDC (as listed)64380-749Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64380-0749Add 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
64380-749-05643800749056438007490590 TABLET in 1 BOTTLE (64380-749-05)Marketed from Feb 15, 2021

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 — .75 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Strides Pharma Science LimitedNDC labeler code 64380
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202702
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 64380-749_411af03f-06f1-4f2c-9f51-cacfef78233bSPL ID 411af03f-06f1-4f2c-9f51-cacfef78233bSPL set ID fb2260d6-204c-4d25-a331-0f8340d83a6eRxCUI 858625, 859033, 859040, 859044, 859048, 859052UNII 3D867NP06JUPC 0364380751052, 0364380746058, 0364380750055, 0364380748052, 0364380749059, 0364380747055
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

N464380074905 followed by a unit qualifier and the quantity

Package 64380-0749-05. 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 tablets is 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)

About NDC 64380-749

What is NDC 64380-749?
64380-749 is the product NDC for pramipexole dihydrochloride, Pramipexole dihydrochloride .75 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. 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?
Strides Pharma Science Limited, NDC labeler code 64380. 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 4.5 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-33750742-0337-30
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

All 128 pramipexole dihydrochloride NDCs

Other NDCs under ANDA 202702

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

FDA NDC Directory listings under ANDA 202702
ProductStrengthForm · routeLabelerProduct NDC
pramipexole dihydrochloridePramipexole dihydrochloride .125 mg/1TabletOralStrides Pharma Science Limited64380-746
pramipexole dihydrochloridePramipexole dihydrochloride .25 mg/1TabletOralStrides Pharma Science Limited64380-747
pramipexole dihydrochloridePramipexole dihydrochloride .5 mg/1TabletOralStrides Pharma Science Limited64380-748
pramipexole dihydrochloridePramipexole dihydrochloride 1 mg/1TabletOralStrides Pharma Science Limited64380-750
pramipexole dihydrochloridePramipexole dihydrochloride 1.5 mg/1TabletOralStrides Pharma Science Limited64380-751

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