FDA.reportPublic FDA data

Chlorthalidone

Product NDC
62135-506
11-digit product format
621350506
Labeler code
62135
Product ID
62135-506_459bb5c2-1a17-e530-e063-6294a90a8e0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA211063
Marketing category
ANDA
Marketing start
2019-02-26
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
62135-506-30Chlorthalidone30 in 1 BOTTLETABLET304
62135-506-90Chlorthalidone90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-506-30EA - Each62135-506ac6a2cb1-241b-4646-ae4d-403a42a4379812022-03-09
62135-506-90EA - Each62135-5062401f216-1d0d-4f20-aa15-25249fc95bcb12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-506CHLORTHALIDONE (CHLORTHALIDONE) TABLET [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 2 package rows20241011_648f005f-1eae-4718-bc3a-2587d706fae2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSN648f005f-1eae-4718-bc3a-2587d706fae24
197500chlorthalidone 50 MG Oral TabletPSN648f005f-1eae-4718-bc3a-2587d706fae24
197499chlorthalidone 25 MG Oral TabletSCD648f005f-1eae-4718-bc3a-2587d706fae24
197500chlorthalidone 50 MG Oral TabletSCD648f005f-1eae-4718-bc3a-2587d706fae24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-506-306213505063030 TABLET in 1 BOTTLE (62135-506-30) 30 tablet2022-02-070000-00-00NoNoCurrent
62135-506-906213505069090 TABLET in 1 BOTTLE (62135-506-90) 90 tablet2022-02-070000-00-00NoNoCurrent