PRAMIPEXOLE DIHYDROCHLORIDE

Product NDC
69844-044
11-digit product format
698440044
Labeler code
69844
Product ID
69844-044_b8230032-fa60-4c04-b5e3-6544654cb5d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAMIPEXOLE DIHYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Graviti Pharmaceuticals Private Limited
Application
ANDA211088
Marketing category
ANDA
Marketing start
2020-04-06
Marketing end
0000-00-00
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69844-044-012025-01-22C16284748780-1d6a99b39-d7c5-a426-e053-dadaa90af4c285c8649f-2bde-4bb8-9f57-f609934346d1
69844-044-012022-01-28C16284748780-1d6a99b39-d7c5-a426-e053-dadaa90af4c285c8649f-2bde-4bb8-9f57-f609934346d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69844-044-016984400440190 TABLET in 1 BOTTLE (69844-044-01) 90 tablet2020-04-060000-00-00NoNoCurrent