ropinirole

Product NDC
70518-2750
11-digit product format
705182750
Labeler code
70518
Product ID
70518-2750_cd8cbac2-f6c8-115f-e053-2a95a90a0079
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204022
Marketing category
ANDA
Marketing start
2020-05-22
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2750-02023-03-13C16284748780-1f386c64a-05b5-0266-e053-dadaa90a7c1a9d6a1c8d-7fcc-40f6-841a-311a0cf2c601
70518-2750-02023-01-30C16284748780-1f386c64a-05b5-0266-e053-dadaa90a7c1a9d6a1c8d-7fcc-40f6-841a-311a0cf2c601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2750-070518275000180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2750-0) 2020-05-220000-00-00NoNoCurrent