FDA.reportPublic FDA data

Actos

Product NDC
21695-147
11-digit product format
216950147
Labeler code
21695
Product ID
21695-147_fd156adc-3174-44da-bff7-eeaef5983f18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
NDA021073
Marketing category
NDA
Marketing start
1999-07-15
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
15 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
E
Listing certified through
2017-12-31
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
21695-147-152019-09-24C16284748780-1934fe258-4854-48b1-e053-8cdaa90a720aACTOS ® (pioglitazone hydrochloride) Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-147-15Actos15 in 1 BOTTLETABLET157

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-147-15EA - Each21695-1478bc4cd8d-ee08-4b0b-b554-edd838d4f06012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pioglitazone hydrochlorideACTIVE INGREDIENTJQT35NPK6CACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.]7
pioglitazoneACTIVE MOIETYX4OV71U42SACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-147ACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.]7Legacy NDC, 1 package rows20100909_fd156adc-3174-44da-bff7-eeaef5983f18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261266Actos 15 MG Oral TabletPSNfd156adc-3174-44da-bff7-eeaef5983f187
261267Actos 30 MG Oral TabletPSNfd156adc-3174-44da-bff7-eeaef5983f187
317573pioglitazone 15 MG Oral TabletPSNfd156adc-3174-44da-bff7-eeaef5983f187
312440pioglitazone 30 MG Oral TabletPSNfd156adc-3174-44da-bff7-eeaef5983f187
261266pioglitazone 15 MG Oral Tablet [Actos]SBDfd156adc-3174-44da-bff7-eeaef5983f187
261267pioglitazone 30 MG Oral Tablet [Actos]SBDfd156adc-3174-44da-bff7-eeaef5983f187
317573pioglitazone 15 MG Oral TabletSCDfd156adc-3174-44da-bff7-eeaef5983f187
312440pioglitazone 30 MG Oral TabletSCDfd156adc-3174-44da-bff7-eeaef5983f187
261266Actos (as pioglitazone hydrochloride) 15 MG Oral TabletSYfd156adc-3174-44da-bff7-eeaef5983f187
261267Actos (as pioglitazone hydrochloride) 30 MG Oral TabletSYfd156adc-3174-44da-bff7-eeaef5983f187
261266Actos 15 MG Oral TabletSYfd156adc-3174-44da-bff7-eeaef5983f187
261267Actos 30 MG Oral TabletSYfd156adc-3174-44da-bff7-eeaef5983f187
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYfd156adc-3174-44da-bff7-eeaef5983f187
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYfd156adc-3174-44da-bff7-eeaef5983f187

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-147-152169501471515 in 1 BOTTLEHistorical