FDA.reportPublic FDA data

CHLORTHALIDONE

Product NDC
71610-682
11-digit product format
716100682
Labeler code
71610
Product ID
71610-682_cb38eff9-6aab-40c4-9754-7fd9824fa56f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORTHALIDONE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA210742
Marketing category
ANDA
Marketing start
2022-10-20
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
71610-682-16CHLORTHALIDONE6000 in 1 BOTTLETABLET60002
71610-682-30CHLORTHALIDONE30 in 1 BOTTLETABLET302
71610-682-45CHLORTHALIDONE45 in 1 BOTTLETABLET452
71610-682-53CHLORTHALIDONE60 in 1 BOTTLETABLET602
71610-682-60CHLORTHALIDONE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-682-16EA - Each71610-682c880cf71-e9f1-43c2-8ebb-c03b11cd2bb412023-10-16
71610-682-30EA - Each71610-682ed6764e6-e0d3-4e85-aac8-6f1baa497af612024-01-04
71610-682-60EA - Each71610-6822d562591-eda9-4034-877d-a04347b6dbb612023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-682CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 5 package rows20230105_e3ff03fd-bbab-4c8d-b24d-40c611db3bb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNe3ff03fd-bbab-4c8d-b24d-40c611db3bb32
197499chlorthalidone 25 MG Oral TabletSCDe3ff03fd-bbab-4c8d-b24d-40c611db3bb32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-682-16716100682166000 TABLET in 1 BOTTLE (71610-682-16) 6000 tablet2022-12-280000-00-00NoNoCurrent
71610-682-307161006823030 TABLET in 1 BOTTLE (71610-682-30) 30 tablet2022-12-190000-00-00NoNoCurrent
71610-682-457161006824545 TABLET in 1 BOTTLE (71610-682-45) 45 tablet2022-12-280000-00-00NoNoCurrent
71610-682-537161006825360 TABLET in 1 BOTTLE (71610-682-53) 60 tablet2022-12-190000-00-00NoNoCurrent
71610-682-607161006826090 TABLET in 1 BOTTLE (71610-682-60) 90 tablet2022-12-190000-00-00NoNoCurrent