FDA.reportPublic FDA data

Chlorthalidone

Product NDC
51655-790
11-digit product format
516550790
Labeler code
51655
Product ID
51655-790_4973a87d-2797-b84b-e063-6394a90a0f36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA207222
Marketing category
ANDA
Marketing start
2021-11-04
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
51655-790-26Chlorthalidone90 in 1 BOTTLE, PLASTICTABLET904
51655-790-52Chlorthalidone30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-790CHLORTHALIDONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20241228_da829c8c-ae13-510b-e053-2995a90a70b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNda829c8c-ae13-510b-e053-2995a90a70b84
197499chlorthalidone 25 MG Oral TabletSCDda829c8c-ae13-510b-e053-2995a90a70b84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-790-265165507902690 TABLET in 1 BOTTLE, PLASTIC (51655-790-26) 90 tablet2021-11-04NoNoCurrent
51655-790-525165507905230 TABLET in 1 BOTTLE, PLASTIC (51655-790-52) 30 tablet2021-11-04NoNoCurrent