FDA.reportPublic FDA data

CHLORTHALIDONE

Product NDC
51655-526
11-digit product format
516550526
Labeler code
51655
Product ID
51655-526_4871506f-43ad-cafb-e063-6294a90a6832
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORTHALIDONE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA210742
Marketing category
ANDA
Marketing start
2022-07-06
Substance
CHLORTHALIDONE
Active strength
25 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
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
51655-526-26CHLORTHALIDONE90 in 1 BOTTLE, PLASTICTABLET902
51655-526-52CHLORTHALIDONE30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-526CHLORTHALIDONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20230328_f319c0c7-182b-70ee-e053-2a95a90ac5ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNf319c0c7-182b-70ee-e053-2a95a90ac5ef2
197499chlorthalidone 25 MG Oral TabletSCDf319c0c7-182b-70ee-e053-2a95a90ac5ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-526-265165505262690 TABLET in 1 BOTTLE, PLASTIC (51655-526-26) 90 tablet2022-07-06NoNoCurrent
51655-526-525165505265230 TABLET in 1 BOTTLE, PLASTIC (51655-526-52) 30 tablet2022-12-02NoNoCurrent