FDA.reportPublic FDA data

PIOGLITAZONE

Product NDC
43547-428
11-digit product format
435470428
Labeler code
43547
Product ID
43547-428_258c9ca5-41a1-44dc-8d3a-958bf6613e40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare LLC
Application
ANDA207806
Marketing category
ANDA
Marketing start
2018-05-20
Substance
PIOGLITAZONE
Active strength
45 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PIOGLITAZONE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIOGLITAZONE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4OV71U42S
Rxcui312440, 312441, 317573

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-428-03PIOGLITAZONE30 in 1 BOTTLETABLET303
43547-428-09PIOGLITAZONE90 in 1 BOTTLETABLET903
43547-428-50PIOGLITAZONE500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-428-03EA - Each43547-42824aede74-1d37-44b2-953a-8e2c4fffa13012018-08-13
43547-428-09EA - Each43547-4289be3a0e5-5f69-49ea-bf3e-d68c35e09d8d12018-08-13
43547-428-50EA - Each43547-4281e5e4ac5-6c4f-4e22-ba55-b228d1ff7d6c12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-428PIOGLITAZONE TABLET [SOLCO HEALTHCARE LLC]3Current NDC, Legacy NDC, 3 package rows20221118_1b77dbeb-61d1-4df3-872b-2f4f75a110db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN1b77dbeb-61d1-4df3-872b-2f4f75a110db3
312440pioglitazone 30 MG Oral TabletPSN1b77dbeb-61d1-4df3-872b-2f4f75a110db3
312441pioglitazone 45 MG Oral TabletPSN1b77dbeb-61d1-4df3-872b-2f4f75a110db3
317573pioglitazone 15 MG Oral TabletSCD1b77dbeb-61d1-4df3-872b-2f4f75a110db3
312440pioglitazone 30 MG Oral TabletSCD1b77dbeb-61d1-4df3-872b-2f4f75a110db3
312441pioglitazone 45 MG Oral TabletSCD1b77dbeb-61d1-4df3-872b-2f4f75a110db3
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY1b77dbeb-61d1-4df3-872b-2f4f75a110db3
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY1b77dbeb-61d1-4df3-872b-2f4f75a110db3
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY1b77dbeb-61d1-4df3-872b-2f4f75a110db3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-428-034354704280330 TABLET in 1 BOTTLE (43547-428-03) 30 tablet2018-05-200000-00-00NoNoCurrent
43547-428-094354704280990 TABLET in 1 BOTTLE (43547-428-09) 90 tablet2018-05-200000-00-00NoNoCurrent
43547-428-5043547042850500 TABLET in 1 BOTTLE (43547-428-50) 500 tablet2018-05-200000-00-00NoNoCurrent