FDA.reportPublic FDA data

Chlorthalidone

Product NDC
0378-0213
11-digit product format
003780213
Labeler code
0378
Product ID
0378-0213_21d4a0c6-4112-42bd-8738-2df8d81debf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA086831
Marketing category
ANDA
Marketing start
1981-02-26
Substance
CHLORTHALIDONE
Active strength
50 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorthalidone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORTHALIDONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ0MQD1073Q
Rxcui197499, 197500

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83fe98fe-2a14-448c-9029-41f7600d1b0aProduct name120260105
0450926f-f624-49c2-83be-42807e8fbcd5Product name120251113
8525e779-537f-e5cc-2515-089ecce5f50fProduct name920221128
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
3f5e2da3-8b99-f714-3261-2c998ee07b05Product name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-0213-01Chlorthalidone100 in 1 BOTTLETABLET10013
0378-0213-10Chlorthalidone1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0213-01EA - Each0378-0213a76112bf-2f47-47e0-9aea-d6281024deae12012-07-24
0378-0213-10EA - Each0378-0213374c4dd2-65c7-40fa-8729-dc0b9b8ac91512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QCHLORTHALIDONE TABLET [MYLAN PHARMACEUTICALS INC.]5
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QCHLORTHALIDONE TABLET [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORTHALIDONE TABLET [MYLAN PHARMACEUTICALS INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORTHALIDONE TABLET [MYLAN PHARMACEUTICALS INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORTHALIDONE TABLET [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHLORTHALIDONE TABLET [MYLAN PHARMACEUTICALS INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHLORTHALIDONE TABLET [MYLAN PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLORTHALIDONE TABLET [MYLAN PHARMACEUTICALS INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCHLORTHALIDONE TABLET [MYLAN PHARMACEUTICALS INC.]5
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QCHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QCHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0213CHLORTHALIDONE TABLET [MYLAN PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 2 package rows20240111_15dd224a-87ad-48dc-80b1-e8382a452c4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSN15dd224a-87ad-48dc-80b1-e8382a452c4c13
197500chlorthalidone 50 MG Oral TabletPSN15dd224a-87ad-48dc-80b1-e8382a452c4c13
197499chlorthalidone 25 MG Oral TabletSCD15dd224a-87ad-48dc-80b1-e8382a452c4c13
197500chlorthalidone 50 MG Oral TabletSCD15dd224a-87ad-48dc-80b1-e8382a452c4c13
197500chlorthalidone 50 MG Oral TabletPSNc0f9093a-0c6a-47c6-b4f8-c3685f13be041
197500chlorthalidone 50 MG Oral TabletSCDc0f9093a-0c6a-47c6-b4f8-c3685f13be041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0213-0100378021301100 TABLET in 1 BOTTLE (0378-0213-01) 100 tablet1981-02-260000-00-00NoNoCurrent
0378-0213-10003780213101000 TABLET in 1 BOTTLE (0378-0213-10) 1000 tablet1981-02-260000-00-00NoNoCurrent