FDA.reportPublic FDA data

Chlorthalidone

Product NDC
67877-697
11-digit product format
678770697
Labeler code
67877
Product ID
67877-697_c8bc4f9d-d8fe-47fa-8643-95a371c5d23b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA213412
Marketing category
ANDA
Marketing start
2020-02-13
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
67877-697-01Chlorthalidone100 in 1 BOTTLETABLET1007
67877-697-10Chlorthalidone1000 in 1 BOTTLETABLET10007
67877-697-33Chlorthalidone1 in 1 CARTONTABLET17
67877-697-33Chlorthalidone10 in 1 BLISTER PACKTABLET107
67877-697-38Chlorthalidone10 in 1 CARTONTABLET107
67877-697-38Chlorthalidone10 in 1 BLISTER PACKTABLET107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-697-01EA - Each67877-697e644ff4a-aa11-4ac1-b7ed-0c11a41e60c512020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-697CHLORTHALIDONE TABLET [ASCEND LABORATORIES, LLC]7Current NDC, Legacy NDC, 6 package rows20250425_d104583e-e983-4230-b6d1-4455ee1060a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197500chlorthalidone 50 MG Oral TabletPSNe727d42f-e4e1-4cf6-9d7a-6ec2333bc6d1104
197500chlorthalidone 50 MG Oral TabletSCDe727d42f-e4e1-4cf6-9d7a-6ec2333bc6d1104
197499chlorthalidone 25 MG Oral TabletPSNd104583e-e983-4230-b6d1-4455ee1060a57
197500chlorthalidone 50 MG Oral TabletPSN583992c2-b789-4267-9a8f-c1ee5db3f29f7
197500chlorthalidone 50 MG Oral TabletPSNd104583e-e983-4230-b6d1-4455ee1060a57
197499chlorthalidone 25 MG Oral TabletSCDd104583e-e983-4230-b6d1-4455ee1060a57
197500chlorthalidone 50 MG Oral TabletSCD583992c2-b789-4267-9a8f-c1ee5db3f29f7
197500chlorthalidone 50 MG Oral TabletSCDd104583e-e983-4230-b6d1-4455ee1060a57
197500chlorthalidone 50 MG Oral TabletPSN165e5993-eb9d-4664-97dc-574ae5e0e9462
197500chlorthalidone 50 MG Oral TabletSCD165e5993-eb9d-4664-97dc-574ae5e0e9462
197500chlorthalidone 50 MG Oral TabletPSN2ccba8ab-4c34-af52-e063-6394a90a78d31
197500chlorthalidone 50 MG Oral TabletSCD2ccba8ab-4c34-af52-e063-6394a90a78d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-697-0167877069701100 TABLET in 1 BOTTLE (67877-697-01) 100 tablet2020-02-130000-00-00NoNoCurrent
67877-697-10678770697101000 TABLET in 1 BOTTLE (67877-697-10) 1000 tablet2020-02-130000-00-00NoNoCurrent
67877-697-33678770697331 BLISTER PACK in 1 CARTON (67877-697-33) / 10 TABLET in 1 BLISTER PACK1 blister pack2020-02-130000-00-00NoNoCurrent
67877-697-386787706973810 BLISTER PACK in 1 CARTON (67877-697-38) / 10 TABLET in 1 BLISTER PACK10 blister pack2020-02-130000-00-00NoNoCurrent