Prescription drug · ANDA

ropinirole NDC 70518-3478

Ropinirole hydrochloride .5 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3478Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3478Add 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
70518-3478-0705183478007051834780030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3478-0)Marketed from Aug 17, 2022
70518-3478-1705183478017051834780190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-1)Marketed from Feb 20, 2023
70518-3478-2705183478027051834780260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-2)Marketed from Jun 18, 2025
70518-3478-3705183478037051834780330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-3)Marketed from Mar 9, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
ropinirole
Generic name (nonproprietary)
ropinirole
Active ingredients
Ropinirole hydrochloride — .5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090135
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 70518-3478_4c9d34b8-c7bd-a9fa-e063-6294a90aad46SPL ID 4c9d34b8-c7bd-a9fa-e063-6294a90aad46SPL set ID 16752e1b-10eb-4c31-92d4-ff6c6e8466f4RxCUI 312846UNII D7ZD41RZI9
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

N470518347800 followed by a unit qualifier and the quantity

Package 70518-3478-00. 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)

Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1 , 1.2 ) 1.1 Parkinson's Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease. 1.2 Restless Legs Syndrome Ropinirole 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 70518-3478

What is NDC 70518-3478?
70518-3478 is the product NDC for ropinirole, Ropinirole hydrochloride .5 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
ropinirole.
What is the active ingredient?
Ropinirole hydrochloride.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ropinirole?
110 other product NDCs are listed under this name. See all ropinirole 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 ropinirole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ropiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-413868788-4138-03
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260272162-2602-0372162-2602-09
RopiniroleRopinirole hydrochloride 4 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260372162-2603-0372162-2603-09
RopiniroleRopinirole hydrochloride 6 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260472162-2604-0372162-2604-09
RopiniroleRopinirole hydrochloride 8 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260572162-2605-0372162-2605-09
RopiniroleRopinirole hydrochloride 12 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260672162-2606-0372162-2606-09
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Extended releaseOralElite Laboratories, Inc.64850-25064850-0250-30
RopiniroleRopinirole hydrochloride 4 mg/1Tablet, Extended releaseOralElite Laboratories, Inc.64850-25164850-0251-30
RopiniroleRopinirole hydrochloride 6 mg/1Tablet, Extended releaseOralElite Laboratories, Inc.64850-25264850-0252-30
RopiniroleRopinirole hydrochloride 8 mg/1Tablet, Extended releaseOralElite Laboratories, Inc.64850-25364850-0253-30

All 111 ropinirole NDCs

Other NDCs under ANDA 090135

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

FDA NDC Directory listings under ANDA 090135
ProductStrengthForm · routeLabelerProduct NDC
ropiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1822
ropiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4684
ropiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-253
ropiniroleRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-254
ropiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-255
ropiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-256
ropiniroleRopinirole hydrochloride 3 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-257
ropiniroleRopinirole hydrochloride 4 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-258
ropiniroleRopinirole hydrochloride 5 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-259
ropiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-4138
ropiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3482
ropiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3618
ropiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0447
ropiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0631
RopiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralDirect_Rx72189-416

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