FDA.reportPublic FDA data

PIOGLITAZONEHYDROCHLORIDE

Product NDC
13668-119
11-digit product format
136680119
Labeler code
13668
Product ID
13668-119_7f0dc425-63ae-4c7f-bc31-0c594218844b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIOGLITAZONEHYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA091298
Marketing category
ANDA
Marketing start
2013-02-13
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e11f0f31-8914-938f-521e-037b6de27c13Product name520210621
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13668-119-052023-03-09C16284748780-1ba0f9c33-3987-a910-e053-dadaa90a0b853d11a0bc-26b4-49f4-a8e7-0fad1524b3d1
13668-119-302023-03-09C16284748780-1ba0f9c33-3987-a910-e053-dadaa90a0b853d11a0bc-26b4-49f4-a8e7-0fad1524b3d1
13668-119-522023-03-09C16284748780-1ba0f9c33-3987-a910-e053-dadaa90a0b853d11a0bc-26b4-49f4-a8e7-0fad1524b3d1
13668-119-742023-03-09C16284748780-1ba0f9c33-3987-a910-e053-dadaa90a0b853d11a0bc-26b4-49f4-a8e7-0fad1524b3d1
13668-119-902023-03-09C16284748780-1ba0f9c33-3987-a910-e053-dadaa90a0b853d11a0bc-26b4-49f4-a8e7-0fad1524b3d1
13668-119-052021-01-29C16284748780-1ba0f9c33-3987-a910-e053-dadaa90a0b853d11a0bc-26b4-49f4-a8e7-0fad1524b3d1
13668-119-302021-01-29C16284748780-1ba0f9c33-3987-a910-e053-dadaa90a0b853d11a0bc-26b4-49f4-a8e7-0fad1524b3d1
13668-119-522021-01-29C16284748780-1ba0f9c33-3987-a910-e053-dadaa90a0b853d11a0bc-26b4-49f4-a8e7-0fad1524b3d1
13668-119-742021-01-29C16284748780-1ba0f9c33-3987-a910-e053-dadaa90a0b853d11a0bc-26b4-49f4-a8e7-0fad1524b3d1
13668-119-902021-01-29C16284748780-1ba0f9c33-3987-a910-e053-dadaa90a0b853d11a0bc-26b4-49f4-a8e7-0fad1524b3d1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-119-05EA - Each13668-1197670dca6-8692-40da-b6e0-fbbf0b09851d12013-03-03
13668-119-30EA - Each13668-119af44ea96-2eb2-4bc8-92d8-875b69f64db712013-03-03
13668-119-90EA - Each13668-119357b3702-a756-44e9-a9cb-b1eaab8fa57712013-03-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312440pioglitazone 30 MG Oral TabletPSN74adf887-3cfe-41b8-9696-e2535874aad64
312440pioglitazone 30 MG Oral TabletSCD74adf887-3cfe-41b8-9696-e2535874aad64
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY74adf887-3cfe-41b8-9696-e2535874aad64