CHLORTHALIDONE

Product NDC
62332-676
11-digit product format
623320676
Labeler code
62332
Product ID
62332-676_56256d08-66bc-4424-84d4-2db217e5f4d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORTHALIDONE
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA216262
Marketing category
ANDA
Marketing start
2022-08-29
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
A216262-001CHLORTHALIDONECHLORTHALIDONE25MGTABLET / ORALAB2022-08-26
A216262-002CHLORTHALIDONECHLORTHALIDONE50MGTABLET / ORALAB2022-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216262-001AB
A216262-002AB

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 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-268072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-266a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-261c564ffb4f44…
2024-02-18 07:12 UTC2024-02A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-26ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-26a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-269b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216262-001CHLORTHALIDONE25MGTABLET / ORALAB2022-08-26a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216262-002CHLORTHALIDONE50MGTABLET / ORALAB2022-08-26a67488948f0b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216262-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216262-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216262-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216262-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216262-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216262-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216262-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216262-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216262-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216262-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216262-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216262-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216262-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216262-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216262-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216262-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216262-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216262-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216262-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216262-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216262-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216262-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216262-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216262-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216262-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216262-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216262-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A216262-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216262-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216262-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216262-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A216262-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216262-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A216262-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216262-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216262-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216262-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216262-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216262-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216262-002AB1a67488948f0b…

Additional Listing Data#

Finished product
Yes
Brand name base
CHLORTHALIDONE
Brand name suffix
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
a1043a72-8e64-49da-a7e4-eadee083022eAvailable 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
62332-676-31CHLORTHALIDONECHLORTHALIDONE100 in 1 BOTTLETABLET1002
62332-676-90CHLORTHALIDONECHLORTHALIDONE90 in 1 BOTTLETABLET902
62332-676-91CHLORTHALIDONECHLORTHALIDONE1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-676-31EA - Each62332-6762bb7ffe6-3df2-4ec5-8747-b2e161fd4e6c12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-676CHLORTHALIDONE CHLORTHALIDONE (CHLORTHALIDONE) TABLET [ALEMBIC PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 3 package rows20220904_a1043a72-8e64-49da-a7e4-eadee083022e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHLORTHALIDONE CHLORTHALIDONECHLORTHALIDONEAlembic Pharmaceuticals Limited1b98d1a1-9d3d-41d2-a5e9-744b851d30d42022-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216262
application number: ANDA216262
CHLORTHALIDONE CHLORTHALIDONECHLORTHALIDONEAlembic Pharmaceuticals Inc.a1043a72-8e64-49da-a7e4-eadee083022e2022-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216262
application number: ANDA216262
ndc (product): 62332-676

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNa1043a72-8e64-49da-a7e4-eadee083022e2
197500chlorthalidone 50 MG Oral TabletPSNa1043a72-8e64-49da-a7e4-eadee083022e2
197499chlorthalidone 25 MG Oral TabletSCDa1043a72-8e64-49da-a7e4-eadee083022e2
197500chlorthalidone 50 MG Oral TabletSCDa1043a72-8e64-49da-a7e4-eadee083022e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-676-3162332067631100 TABLET in 1 BOTTLE (62332-676-31) 100 tablet2022-08-290000-00-00NoNoCurrent
62332-676-906233206769090 TABLET in 1 BOTTLE (62332-676-90) 90 tablet2022-08-290000-00-00NoNoCurrent
62332-676-91623320676911000 TABLET in 1 BOTTLE (62332-676-91) 1000 tablet2022-08-290000-00-00NoNoCurrent