NDC codes

FDA NDC Directory
Product NDC (as listed)29300-207Labeler and product segments. Claims need a package NDC.
Product NDC at billing width29300-0207Add 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
29300-207-1029300020710293000207101000 TABLET in 1 BOTTLE, PLASTIC (29300-207-10)Marketed from Mar 1, 2019
29300-207-16293000207162930002071660 TABLET in 1 BOTTLE, PLASTIC (29300-207-16)Marketed from Mar 1, 2019
29300-207-19293000207192930002071990 TABLET in 1 BOTTLE, PLASTIC (29300-207-19)Marketed from Mar 1, 2019

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 — .125 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Unichem Pharmaceuticals (USA), Inc.NDC labeler code 29300
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207011
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 29300-207_2ab8bb44-e4ba-4ae0-8ce9-0e9153de59f3SPL ID 2ab8bb44-e4ba-4ae0-8ce9-0e9153de59f3SPL set ID b978aa75-c62d-444b-9ec6-6c0d21a66688RxCUI 858625, 859033, 859040, 859044, 859048, 859052UNII 3D867NP06J
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

N429300020710 followed by a unit qualifier and the quantity

Package 29300-0207-10. 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 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 29300-207

What is NDC 29300-207?
29300-207 is the product NDC for pramipexole dihydrochloride, Pramipexole dihydrochloride .125 mg/1 tablet, listed with the FDA by Unichem Pharmaceuticals (USA), Inc.. It has 3 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?
Unichem Pharmaceuticals (USA), Inc., NDC labeler code 29300. 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 207011

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

FDA NDC Directory listings under ANDA 207011
ProductStrengthForm · routeLabelerProduct NDC
pramipexole dihydrochloridePramipexole dihydrochloride .25 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-208
pramipexole dihydrochloridePramipexole dihydrochloride .5 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-209
pramipexole dihydrochloridePramipexole dihydrochloride 1 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-210
pramipexole dihydrochloridePramipexole dihydrochloride 1.5 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-211
pramipexole dihydrochloridePramipexole dihydrochloride .75 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-270

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