What is NDC 16714-916?

16714-916 is the product NDC for Pramipexole Dihydrochloride, Pramipexole dihydrochloride .375 mg/1 tablet, extended release, listed with the FDA by NorthStar RxLLC. It has 1 package NDC, shown above in 10- and 11-digit form.

NorthStar RxLLC, NDC labeler code 16714. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pramipexole Dihydrochloride NDC 16714-916

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-916Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0916Add 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
16714-916-01	1671409160116714091601	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-916-01)Marketed from Mar 6, 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 — .375 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: NorthStar RxLLCNDC labeler code 16714
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206156
Marketing start: Mar 6, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Dopamine Agonists (Mechanism)
Identifiers: Product ID 16714-916_b78c4a9c-3ad8-443e-ada5-853385411cfcSPL ID b78c4a9c-3ad8-443e-ada5-853385411cfcSPL set ID 946c8a72-8c48-4925-93d3-7940f4c0fd29RxCUI 901534, 901541, 901546, 901550, 901555, 1114479UNII 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

N416714091601 followed by a unit qualifier and the quantity

Package 16714-0916-01. 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 Aug 20, 2024.

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 16714-916

What is NDC 16714-916?: 16714-916 is the product NDC for Pramipexole Dihydrochloride, Pramipexole dihydrochloride .375 mg/1 tablet, extended release, listed with the FDA by NorthStar RxLLC. 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?: NorthStar RxLLC, NDC labeler code 16714. 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
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 2.25 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-334	50742-0334-30
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 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 1 mg/1	TabletOral	Strides Pharma Science Limited	64380-750	64380-0750-0164380-0750-05

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
Product	Strength	Form · route	Labeler	Product NDC
Pramipexole Dihydrochloride	Pramipexole dihydrochloride .75 mg/1	Tablet, Extended releaseOral	NorthStar RxLLC	16714-917
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 1.5 mg/1	Tablet, Extended releaseOral	NorthStar RxLLC	16714-918
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 2.25 mg/1	Tablet, Extended releaseOral	NorthStar RxLLC	16714-919
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 3 mg/1	Tablet, Extended releaseOral	NorthStar RxLLC	16714-920
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 4.5 mg/1	Tablet, Extended releaseOral	NorthStar RxLLC	16714-922
Pramipexole Dihydrochloride	Pramipexole dihydrochloride .375 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-208
Pramipexole Dihydrochloride	Pramipexole dihydrochloride .75 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-209
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 1.5 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-210
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 2.25 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-211
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 3 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-212
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 3.75 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-213
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 4.5 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-214