What is NDC 46708-005?

46708-005 is the product NDC for Pramipexole Dihydrochloride, Pramipexole dihydrochloride .5 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-005

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0005Add 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
46708-005-90	4670800059046708000590	90 TABLET in 1 BOTTLE (46708-005-90)Marketed from Mar 22, 2016

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 — .5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078894
Marketing start: Mar 22, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Dopamine Agonists (Mechanism)
Identifiers: Product ID 46708-005_92f6ef1e-3256-45a7-a409-80dd85e95187SPL ID 92f6ef1e-3256-45a7-a409-80dd85e95187SPL set ID 92f6ef1e-3256-45a7-a409-80dd85e95187RxCUI 859033, 859040, 859044, 859048, 859052UNII 3D867NP06JUPC 0346708005900, 0346708007904, 0346708006907, 0346708003906, 0346708004903
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

N446708000590 followed by a unit qualifier and the quantity

Package 46708-0005-90. 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 Nov 20, 2017.

Indications (excerpt from the label)

Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of: · Parkinson’s disease (PD) (1.1) 1.1 Parkinson's Disease Pramipexole dihydrochloride 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 46708-005

What is NDC 46708-005?: 46708-005 is the product NDC for Pramipexole Dihydrochloride, Pramipexole dihydrochloride .5 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 2.25 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-334	50742-0334-30
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 4.5 mg/1	Tablet, Extended releaseOral	Ingenus Pharmaceuticals, LLC	50742-337	50742-0337-30
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 .75 mg/1	Tablet, Extended releaseOral	Vitruvias Therapeutics, Inc.	69680-146	69680-0146-30
pramipexole dihydrochloride	Pramipexole dihydrochloride .25 mg/1	TabletOral	Strides Pharma Science Limited	64380-747	64380-0747-0164380-0747-05
pramipexole dihydrochloride	Pramipexole dihydrochloride .125 mg/1	TabletOral	Strides Pharma Science Limited	64380-746	64380-0746-05

All 128 Pramipexole Dihydrochloride NDCs

Other NDCs under ANDA 078894

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

FDA NDC Directory listings under ANDA 078894
Product	Strength	Form · route	Labeler	Product NDC
Pramipexole Dihydrochloride	Pramipexole dihydrochloride .125 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-003
Pramipexole Dihydrochloride	Pramipexole dihydrochloride .25 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-004
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 1 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-006
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 1.5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-007
Pramipexole Dihydrochloride	Pramipexole dihydrochloride .125 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-611
Pramipexole Dihydrochloride	Pramipexole dihydrochloride .25 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-612
Pramipexole Dihydrochloride	Pramipexole dihydrochloride .5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-613
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 1 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-614
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 1.5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-615
Pramipexole Dihydrochloride	Pramipexole dihydrochloride .125 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-003
Pramipexole Dihydrochloride	Pramipexole dihydrochloride .25 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-004
Pramipexole Dihydrochloride	Pramipexole dihydrochloride .5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-005
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 1 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-006
Pramipexole Dihydrochloride	Pramipexole dihydrochloride 1.5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-007