Chlorthalidone

Product NDC
71335-1829
11-digit product format
713351829
Labeler code
71335
Product ID
71335-1829_80f21f4f-2bf6-4437-b7d7-9452a14b1e1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211627
Marketing category
ANDA
Marketing start
2019-08-06
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211627-001CHLORTHALIDONECHLORTHALIDONE25MGTABLET / ORALAB2019-08-06
A211627-002CHLORTHALIDONECHLORTHALIDONE50MGTABLET / ORALAB2019-08-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A211627-001AB
A211627-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211627-001CHLORTHALIDONE25MGTABLET / ORALAB2019-08-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A211627-002CHLORTHALIDONE50MGTABLET / ORALAB2019-08-06782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211627-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211627-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211627-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211627-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211627-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211627-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211627-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211627-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211627-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211627-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211627-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211627-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211627-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211627-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211627-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211627-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211627-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211627-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211627-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211627-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211627-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211627-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211627-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211627-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211627-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211627-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211627-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211627-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211627-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211627-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211627-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211627-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211627-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211627-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211627-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211627-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211627-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211627-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211627-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211627-002AB1782e0a99824c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q0MQD1073QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197499Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f19b9a1c-1a43-4317-a016-6104391730dcAvailable on FDA.report

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
71335-1829-1Chlorthalidone30 in 1 BOTTLE, PLASTICTABLET30102
71335-1829-2Chlorthalidone90 in 1 BOTTLE, PLASTICTABLET90102
71335-1829-3Chlorthalidone60 in 1 BOTTLE, PLASTICTABLET60102
71335-1829-4Chlorthalidone8 in 1 BOTTLE, PLASTICTABLET8102
71335-1829-5Chlorthalidone100 in 1 BOTTLE, PLASTICTABLET100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1829CHLORTHALIDONE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20231128_f19b9a1c-1a43-4317-a016-6104391730dc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChlorthalidoneCHLORTHALIDONEBryant Ranch Prepacka73613a3-914f-481a-8e40-8d782bcea03a2026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211627
application number: ANDA211627
ChlorthalidoneCHLORTHALIDONEPreferred Pharmaceuticals Inc.db169e46-9f6e-490e-856f-f60ec9a319802026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211627
application number: ANDA211627
ChlorthalidoneCHLORTHALIDONEDirect_Rxdeab1d3e-759f-480e-e053-2995a90a0a752025-01-22WarningsExact identifier
application applno (ANDA): 211627
application number: ANDA211627
ChlorthalidoneCHLORTHALIDONEBryant Ranch Prepackf19b9a1c-1a43-4317-a016-6104391730dc2023-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211627
application number: ANDA211627
ndc (product): 71335-1829
ChlorthalidoneCHLORTHALIDONEUnichem Pharmaceuticals (USA), Inc.01065eda-7515-46bc-b858-a062c3aa35bd2022-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211627
application number: ANDA211627

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNf19b9a1c-1a43-4317-a016-6104391730dc102
197499chlorthalidone 25 MG Oral TabletSCDf19b9a1c-1a43-4317-a016-6104391730dc102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1829-17133518290130 TABLET in 1 BOTTLE, PLASTIC (71335-1829-1) 30 tablet2021-12-210000-00-00NoNoCurrent
71335-1829-27133518290290 TABLET in 1 BOTTLE, PLASTIC (71335-1829-2) 90 tablet2021-12-210000-00-00NoNoCurrent
71335-1829-37133518290360 TABLET in 1 BOTTLE, PLASTIC (71335-1829-3) 60 tablet2021-12-210000-00-00NoNoCurrent
71335-1829-4713351829048 TABLET in 1 BOTTLE, PLASTIC (71335-1829-4) 8 tablet2021-12-210000-00-00NoNoCurrent
71335-1829-571335182905100 TABLET in 1 BOTTLE, PLASTIC (71335-1829-5) 100 tablet2021-12-210000-00-00NoNoCurrent