FDA.reportPublic FDA data

Chlorthalidone

Product NDC
51224-118
11-digit product format
512240118
Labeler code
51224
Product ID
51224-118_98c8ff40-9e00-4793-ba69-5e36ced32984
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
TAGI Pharma, Inc.
Application
ANDA212875
Marketing category
ANDA
Marketing start
2022-08-05
Substance
CHLORTHALIDONE
Active strength
50 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
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
51224-118-50Chlorthalidone100 in 1 BOTTLETABLET1001
51224-118-70Chlorthalidone1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-118-50EA - Each51224-118998faaa1-3371-4a81-b895-0b9ebe0c529a12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-118CHLORTHALIDONE TABLET [TAGI PHARMA, INC.]1Current NDC, Legacy NDC, 2 package rows20220805_bd92c59b-3a65-47c3-b3c8-37090b4ae464.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197500chlorthalidone 50 MG Oral TabletPSN68244f44-42e9-46b6-86f8-85ab0c4b2b26100
197500chlorthalidone 50 MG Oral TabletSCD68244f44-42e9-46b6-86f8-85ab0c4b2b26100
197499chlorthalidone 25 MG Oral TabletPSNbd92c59b-3a65-47c3-b3c8-37090b4ae4641
197500chlorthalidone 50 MG Oral TabletPSNbd92c59b-3a65-47c3-b3c8-37090b4ae4641
197499chlorthalidone 25 MG Oral TabletSCDbd92c59b-3a65-47c3-b3c8-37090b4ae4641
197500chlorthalidone 50 MG Oral TabletSCDbd92c59b-3a65-47c3-b3c8-37090b4ae4641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51224-118-5051224011850100 TABLET in 1 BOTTLE (51224-118-50) 100 tablet2022-08-050000-00-00NoNoCurrent
51224-118-70512240118701000 TABLET in 1 BOTTLE (51224-118-70) 1000 tablet2022-08-050000-00-00NoNoCurrent