CHLORTHALIDONE

Product NDC
64980-599
11-digit product format
649800599
Labeler code
64980
Product ID
64980-599_6404aaa7-05c8-4f96-a091-3f07248ffbd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA211320
Marketing category
ANDA
Marketing start
2024-10-23
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, 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
64980-599-01CHLORTHALIDONE100 in 1 BOTTLETABLET1003
64980-599-10CHLORTHALIDONE1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-599-01EA - Each64980-59988acc93a-8694-4b0a-95a2-454827dea63e12024-12-10
64980-599-10EA - Each64980-599946fe3c6-075c-47ff-a7a7-626e81a5afc812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-599CHLORTHALIDONE TABLET [RISING PHARMA HOLDINGS, INC.]3Current NDC, 2 package rows20241116_71b1d074-0521-4cd1-beb5-fedd61f52eca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSN71b1d074-0521-4cd1-beb5-fedd61f52eca3
197500chlorthalidone 50 MG Oral TabletPSN71b1d074-0521-4cd1-beb5-fedd61f52eca3
197499chlorthalidone 25 MG Oral TabletSCD71b1d074-0521-4cd1-beb5-fedd61f52eca3
197500chlorthalidone 50 MG Oral TabletSCD71b1d074-0521-4cd1-beb5-fedd61f52eca3
197499chlorthalidone 25 MG Oral TabletPSN50936b5f-3eb8-4ff8-96b3-0aa4a8f77a981
197499chlorthalidone 25 MG Oral TabletPSNf46fd743-3661-41b7-b12d-30d96692f0ee1
197499chlorthalidone 25 MG Oral TabletSCD50936b5f-3eb8-4ff8-96b3-0aa4a8f77a981
197499chlorthalidone 25 MG Oral TabletSCDf46fd743-3661-41b7-b12d-30d96692f0ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-599-0164980059901100 TABLET in 1 BOTTLE (64980-599-01) 100 tablet2024-10-23NoNoCurrent
64980-599-10649800599101000 TABLET in 1 BOTTLE (64980-599-10) 1000 tablet2024-10-23NoNoCurrent