Chlorthalidone

Product NDC
75834-110
11-digit product format
758340110
Labeler code
75834
Product ID
75834-110_4581106c-4e01-7df9-e063-6294a90ac29f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Nivagen Pharmaceuticals, INC.
Application
ANDA207222
Marketing category
ANDA
Marketing start
2018-05-28
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

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
A207222-001CHLORTHALIDONECHLORTHALIDONE25MGTABLET / ORALAB2018-05-24
A207222-002CHLORTHALIDONECHLORTHALIDONE50MGTABLET / ORALAB2018-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207222-001AB
A207222-002AB

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 UTC2026-02A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207222-001CHLORTHALIDONE25MGTABLET / ORALBX2018-05-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207222-002CHLORTHALIDONE50MGTABLET / ORALBX2018-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207222-001CHLORTHALIDONE25MGTABLET / ORALBX2018-05-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207222-002CHLORTHALIDONE50MGTABLET / ORALBX2018-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207222-001CHLORTHALIDONE25MGTABLET / ORALBX2018-05-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207222-002CHLORTHALIDONE50MGTABLET / ORALBX2018-05-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207222-001CHLORTHALIDONE25MGTABLET / ORALAB2018-05-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207222-002CHLORTHALIDONE50MGTABLET / ORALAB2018-05-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207222-001CHLORTHALIDONE25MGTABLET / ORALBX2018-05-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207222-002CHLORTHALIDONE50MGTABLET / ORALBX2018-05-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207222-001CHLORTHALIDONE25MGTABLET / ORALBX2018-05-24782e0a99824c…
2021-12-28 21:50 UTC2021-12A207222-002CHLORTHALIDONE50MGTABLET / ORALBX2018-05-24782e0a99824c…

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 UTC2026-02A207222-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207222-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207222-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207222-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207222-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207222-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207222-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207222-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207222-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207222-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207222-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207222-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207222-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207222-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207222-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207222-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207222-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207222-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207222-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207222-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207222-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207222-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207222-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207222-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207222-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207222-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207222-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207222-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207222-001BX15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207222-002BX15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207222-001BX15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207222-002BX15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207222-001BX14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207222-002BX14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207222-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207222-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207222-001BX1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207222-002BX1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207222-001BX1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207222-002BX1782e0a99824c…

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 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
36ef8d83-45f2-4873-b7cb-1be096d14d18Available 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
75834-110-01Chlorthalidone100 in 1 BOTTLETABLET10015
75834-110-10Chlorthalidone1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-110-01EA - Each75834-110802eee98-a6d1-4bc7-8da1-15b27661645612018-07-03
75834-110-10EA - Each75834-1106247b894-f0f5-47c7-95ed-05492678c56d12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-110CHLORTHALIDONE TABLET [NIVAGEN PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 2 package rows20241225_36ef8d83-45f2-4873-b7cb-1be096d14d18.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChlorthalidoneCHLORTHALIDONEBryant Ranch Prepackbf09d68f-af7a-4057-92f1-13f1ef85d5322026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207222
application number: ANDA207222
ChlorthalidoneCHLORTHALIDONEUmedica Laboratories USA Inc.645734ab-d6aa-4368-9a5a-b550e27177702026-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207222
application number: ANDA207222
ChlorthalidoneCHLORTHALIDONEBryant Ranch Prepackda50019b-60ea-47b3-a355-4ab48efcbe3d2026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207222
application number: ANDA207222
ChlorthalidoneCHLORTHALIDONENorthwind Health Company, LLCda829c8c-ae13-510b-e053-2995a90a70b82026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207222
application number: ANDA207222
ChlorthalidoneCHLORTHALIDONENorthwind Health Company, LLCdf6271ff-f111-fd4a-e053-2a95a90a4b512026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207222
application number: ANDA207222
ChlorthalidoneCHLORTHALIDONENivagen Pharmaceuticals, INC.36ef8d83-45f2-4873-b7cb-1be096d14d182025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207222
application number: ANDA207222
ndc (product): 75834-110
ChlorthalidoneCHLORTHALIDONEBryant Ranch Prepack5979af5a-0c5b-40f9-bb67-2d462e1cefb72025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207222
application number: ANDA207222
ChlorthalidoneCHLORTHALIDONEBryant Ranch Prepack5441e163-459a-46b0-87a9-e9879091bf3c2025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207222
application number: ANDA207222
ChlorthalidoneCHLORTHALIDONEBryant Ranch Prepackac431d1b-b307-46fe-a3a9-29f40fe6742b2025-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207222
application number: ANDA207222
ChlorthalidoneCHLORTHALIDONEProficient Rx LP01337f79-4b3d-4749-a82b-8d56c1aec1792022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207222
application number: ANDA207222

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197500chlorthalidone 50 MG Oral TabletPSNac431d1b-b307-46fe-a3a9-29f40fe6742b106
197500chlorthalidone 50 MG Oral TabletSCDac431d1b-b307-46fe-a3a9-29f40fe6742b106
197500chlorthalidone 50 MG Oral TabletPSN5441e163-459a-46b0-87a9-e9879091bf3c103
197500chlorthalidone 50 MG Oral TabletSCD5441e163-459a-46b0-87a9-e9879091bf3c103
197500chlorthalidone 50 MG Oral TabletPSNda50019b-60ea-47b3-a355-4ab48efcbe3d101
197500chlorthalidone 50 MG Oral TabletSCDda50019b-60ea-47b3-a355-4ab48efcbe3d101
197500chlorthalidone 50 MG Oral TabletPSN5979af5a-0c5b-40f9-bb67-2d462e1cefb7100
197500chlorthalidone 50 MG Oral TabletSCD5979af5a-0c5b-40f9-bb67-2d462e1cefb7100
197499chlorthalidone 25 MG Oral TabletPSN36ef8d83-45f2-4873-b7cb-1be096d14d1815
197500chlorthalidone 50 MG Oral TabletPSN36ef8d83-45f2-4873-b7cb-1be096d14d1815
197499chlorthalidone 25 MG Oral TabletSCD36ef8d83-45f2-4873-b7cb-1be096d14d1815
197500chlorthalidone 50 MG Oral TabletSCD36ef8d83-45f2-4873-b7cb-1be096d14d1815
197500chlorthalidone 50 MG Oral TabletPSNdf6271ff-f111-fd4a-e053-2a95a90a4b513
197500chlorthalidone 50 MG Oral TabletSCDdf6271ff-f111-fd4a-e053-2a95a90a4b513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-110-0175834011001100 TABLET in 1 BOTTLE (75834-110-01) 100 tablet2018-05-280000-00-00NoNoCurrent
75834-110-10758340110101000 TABLET in 1 BOTTLE (75834-110-10) 1000 tablet2018-05-280000-00-00NoNoCurrent