Chlorthalidone

Product NDC
57664-648
11-digit product format
576640648
Labeler code
57664
Product ID
57664-648_eca591c9-75f8-2cbb-e053-2a95a90a7cf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA089286
Marketing category
ANDA
Marketing start
2016-02-12
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
A089286-001CHLORTHALIDONECHLORTHALIDONE50MGTABLET / ORALAB1986-07-21
A089286-002CHLORTHALIDONECHLORTHALIDONE25MGTABLET / ORALAB1986-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089286-001AB
A089286-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089286-001CHLORTHALIDONE50MGTABLET / ORALAB1986-07-21782e0a99824c…
2021-12-28 21:50 UTC2021-12A089286-002CHLORTHALIDONE25MGTABLET / ORALAB1986-07-21782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A089286-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089286-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089286-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089286-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089286-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089286-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089286-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089286-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089286-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089286-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089286-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089286-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089286-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089286-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089286-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089286-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089286-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089286-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089286-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A089286-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089286-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089286-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089286-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089286-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089286-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089286-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089286-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A089286-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089286-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089286-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089286-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A089286-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089286-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A089286-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089286-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A089286-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089286-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A089286-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089286-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A089286-002AB1782e0a99824c…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197499Internal RxNorm lookup
197500Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a304de67-cd2b-4933-937e-4eeecf6cda40Available 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
57664-648-18Chlorthalidone1000 in 1 BOTTLETABLET10006
57664-648-88Chlorthalidone100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-648-88EA - Each57664-648e9d5a627-da12-4d3a-8cae-5ffdcc00047f12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-648CHLORTHALIDONE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 2 package rows20221105_a304de67-cd2b-4933-937e-4eeecf6cda40.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChlorthalidoneCHLORTHALIDONEMajor Pharmaceuticals2de92cea-8f03-4af0-9d91-d4578510cc532026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089286
application number: ANDA089286
ChlorthalidoneCHLORTHALIDONEBryant Ranch Prepack6e5cc0d8-6575-4675-bd8b-9a21b206aae12026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089286
application number: ANDA089286
ChlorthalidoneCHLORTHALIDONEAmerican Health Packagingb1ff748d-36e9-4327-aa8a-e8fb22a9d6372025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089286
application number: ANDA089286
ChlorthalidoneCHLORTHALIDONEPD-Rx Pharmaceuticals, Inc.08b7ee65-53a5-ffbb-e063-6294a90ad4ee2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089286
application number: ANDA089286
ChlorthalidoneCHLORTHALIDONESun Pharmaceutical Industries, Inc.a304de67-cd2b-4933-937e-4eeecf6cda402022-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089286
application number: ANDA089286
ndc (product): 57664-648
ChlorthalidoneCHLORTHALIDONEAphena Pharma Solutions - Tennessee, LLCdea660bd-d4cc-4c5b-9c6d-674a6dc1c9c22021-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089286
application number: ANDA089286
ChlorthalidoneCHLORTHALIDONEAphena Pharma Solutions - Tennessee, LLC5ea42479-84f4-434d-b65b-de34a7a579262017-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089286
application number: ANDA089286

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSN08b7ee65-53a5-ffbb-e063-6294a90ad4ee14
197500chlorthalidone 50 MG Oral TabletPSN08b7ee65-53a5-ffbb-e063-6294a90ad4ee14
197499chlorthalidone 25 MG Oral TabletSCD08b7ee65-53a5-ffbb-e063-6294a90ad4ee14
197500chlorthalidone 50 MG Oral TabletSCD08b7ee65-53a5-ffbb-e063-6294a90ad4ee14
197499chlorthalidone 25 MG Oral TabletPSNb1ff748d-36e9-4327-aa8a-e8fb22a9d6377
197499chlorthalidone 25 MG Oral TabletSCDb1ff748d-36e9-4327-aa8a-e8fb22a9d6377
197499chlorthalidone 25 MG Oral TabletPSNa304de67-cd2b-4933-937e-4eeecf6cda406
197500chlorthalidone 50 MG Oral TabletPSNa304de67-cd2b-4933-937e-4eeecf6cda406
197499chlorthalidone 25 MG Oral TabletSCDa304de67-cd2b-4933-937e-4eeecf6cda406
197500chlorthalidone 50 MG Oral TabletSCDa304de67-cd2b-4933-937e-4eeecf6cda406
197499chlorthalidone 25 MG Oral TabletPSN2de92cea-8f03-4af0-9d91-d4578510cc535
197499chlorthalidone 25 MG Oral TabletPSNee0a3be8-1035-49fa-8a5d-b08cf31a16225
197499chlorthalidone 25 MG Oral TabletSCD2de92cea-8f03-4af0-9d91-d4578510cc535
197499chlorthalidone 25 MG Oral TabletSCDee0a3be8-1035-49fa-8a5d-b08cf31a16225
197499chlorthalidone 25 MG Oral TabletPSNacdd4b78-0d80-4e61-b706-a58eef64d56c2
197499chlorthalidone 25 MG Oral TabletSCDacdd4b78-0d80-4e61-b706-a58eef64d56c2
197499chlorthalidone 25 MG Oral TabletPSN6e5cc0d8-6575-4675-bd8b-9a21b206aae11
197499chlorthalidone 25 MG Oral TabletSCD6e5cc0d8-6575-4675-bd8b-9a21b206aae11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-648-18576640648181000 TABLET in 1 BOTTLE (57664-648-18) 1000 tablet2022-11-040000-00-00NoNoCurrent
57664-648-8857664064888100 TABLET in 1 BOTTLE (57664-648-88) 100 tablet2016-02-120000-00-00NoNoCurrent