Pioglitazone

Product NDC: 68071-2886
11-digit product format: 680712886
Labeler code: 68071
Product ID: 68071-2886_ee00c2b1-e744-2e85-e053-2995a90aa68c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pioglitazone
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA200268
Marketing category: ANDA
Marketing start: 2013-02-13
Marketing end: 0000-00-00
Substance: PIOGLITAZONE HYDROCHLORIDE
Active strength: 15 mg/1
Pharmacologic classes: PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e11f0f31-8914-938f-521e-037b6de27c13	Product name	5	20210621
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8	Product name	1	20140508
ac29cd77-922c-d25a-f8ad-66a8692935c5	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2886-3	2025-01-30	C162847	48780-1	2cef2736-af2c-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS. PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2886-3	Pioglitazone	30 in 1 BOTTLE	TABLET	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2886	PIOGLITAZONE TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20221124_ee00c2b1-e777-2e85-e053-2995a90aa68c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JQT35NPK6C	PIOGLITAZONE HYDROCHLORIDE	112529-15-4	PIOGLITAZONE HYDROCHLORIDE
X4OV71U42S	PIOGLITAZONE	111025-46-8	Pioglitazone

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
317573	pioglitazone 15 MG Oral Tablet	PSN	ee00c2b1-e777-2e85-e053-2995a90aa68c	1
317573	pioglitazone 15 MG Oral Tablet	SCD	ee00c2b1-e777-2e85-e053-2995a90aa68c	1
317573	pioglitazone (as pioglitazone hydrochloride) 15 MG Oral Tablet	SY	ee00c2b1-e777-2e85-e053-2995a90aa68c	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2886-3	68071288603	30 TABLET in 1 BOTTLE (68071-2886-3)	30 tablet	2022-11-21	0000-00-00	No	No	Current