FDA.reportPublic FDA data

Chlorthalidone

Product NDC
55289-067
11-digit product format
552890067
Labeler code
55289
Product ID
55289-067_4198ea35-1b74-f175-e063-6294a90a412e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA086831
Marketing category
ANDA
Marketing start
1981-02-26
Substance
CHLORTHALIDONE
Active strength
25 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORTHALIDONE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ0MQD1073Q
Rxcui197499

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
55289-067-30Chlorthalidone30 in 1 BOTTLE, PLASTICTABLET3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-067-30EA - Each55289-0679a8a0795-5f39-4768-82f4-b8daeb71bb8c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QCHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]2
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QCHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-067CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 1 package rows20241011_bb7112ae-3a37-4525-8c7f-c0f4100ffc0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNbb7112ae-3a37-4525-8c7f-c0f4100ffc0a18
197499chlorthalidone 25 MG Oral TabletSCDbb7112ae-3a37-4525-8c7f-c0f4100ffc0a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-067-305528900673030 TABLET in 1 BOTTLE, PLASTIC (55289-067-30) 30 tablet2016-03-170000-00-00NoNoCurrent