What is NDC 0615-8552?

0615-8552 is the product NDC for Pramipexole dihydrochloride, Pramipexole dihydrochloride .5 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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?

125 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pramipexole dihydrochloride NDC 0615-8552

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8552Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8552Add 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 NDC	11-digit (billing)	Package	Copy
0615-8552-39	00615855239	30 TABLET in 1 BLISTER PACK (0615-8552-39)Marketed from Oct 8, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — .5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090781
Marketing start: Oct 8, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Dopamine Agonists (Mechanism)
Identifiers: Product ID 0615-8552_7d36ceb3-2235-42bc-bb8c-e7863c24b1cbSPL ID 7d36ceb3-2235-42bc-bb8c-e7863c24b1cbSPL set ID 5e6f2187-a5cc-481e-b0a1-d38d3f92e822RxCUI 859040, 859044UNII 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

N400615855239 followed by a unit qualifier and the quantity

Package 00615-8552-39. 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 Oct 9, 2024.

Indications (excerpt from the label)

Pramipexole dihydrochloride tablets are 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 0615-8552

What is NDC 0615-8552?: 0615-8552 is the product NDC for Pramipexole dihydrochloride, Pramipexole dihydrochloride .5 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. 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?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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?: 125 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pramipexole dihydrochloride	Pramipexole dihydrochloride .375 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-331	50742-0331-30
Pramipexole dihydrochloride	Pramipexole dihydrochloride .75 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-332	50742-0332-30
Pramipexole dihydrochloride	Pramipexole dihydrochloride 1.5 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-333	50742-0333-30
Pramipexole dihydrochloride	Pramipexole dihydrochloride 2.25 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-334	50742-0334-30
Pramipexole dihydrochloride	Pramipexole dihydrochloride 3 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-335	50742-0335-30
Pramipexole dihydrochloride	Pramipexole dihydrochloride 3.75 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-336	50742-0336-30
Pramipexole dihydrochloride	Pramipexole dihydrochloride 4.5 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-337	50742-0337-30
Pramipexole Dihydrochloride	Pramipexole dihydrochloride .75 mg/1	Tablet, Extended releaseOral	Vitruvias Therapeutics, Inc.	69680-146	69680-0146-30
pramipexole dihydrochloride	Pramipexole dihydrochloride .125 mg/1	TabletOral	Strides Pharma Science Limited	64380-746	64380-0746-05
pramipexole dihydrochloride	Pramipexole dihydrochloride .25 mg/1	TabletOral	Strides Pharma Science Limited	64380-747	64380-0747-0164380-0747-05

All 126 Pramipexole dihydrochloride NDCs

Other NDCs under ANDA 090781

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

FDA NDC Directory listings under ANDA 090781
Product	Strength	Form · route	Labeler	Product NDC
Pramipexole dihydrochloride	Pramipexole dihydrochloride .25 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8551
Pramipexole dihydrochloride	Pramipexole dihydrochloride .125 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-330
Pramipexole dihydrochloride	Pramipexole dihydrochloride .25 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-331
Pramipexole dihydrochloride	Pramipexole dihydrochloride .5 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-332
Pramipexole dihydrochloride	Pramipexole dihydrochloride 1 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-333
Pramipexole dihydrochloride	Pramipexole dihydrochloride 1.5 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-334
Pramipexole dihydrochloride	Pramipexole dihydrochloride .75 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-627