Chlorthalidone

Product NDC
67877-697
11-digit product format
678770697
Labeler code
67877
Product ID
67877-697_c8bc4f9d-d8fe-47fa-8643-95a371c5d23b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA213412
Marketing category
ANDA
Marketing start
2020-02-13
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
A213412-001CHLORTHALIDONECHLORTHALIDONE25MGTABLET / ORALAB2020-02-11
A213412-002CHLORTHALIDONECHLORTHALIDONE50MGTABLET / ORALABRS2020-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213412-001AB
A213412-002AB

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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-114b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213412-001CHLORTHALIDONE25MGTABLET / ORALAB2020-02-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213412-002CHLORTHALIDONE50MGTABLET / ORALAB2020-02-1187673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213412-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213412-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213412-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213412-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213412-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213412-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213412-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213412-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213412-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213412-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213412-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213412-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213412-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213412-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213412-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213412-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213412-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213412-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213412-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213412-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213412-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213412-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213412-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213412-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213412-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213412-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213412-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213412-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213412-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213412-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213412-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213412-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213412-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213412-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213412-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213412-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213412-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A213412-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213412-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213412-002AB187673890dc5c…

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
d104583e-e983-4230-b6d1-4455ee1060a5Available 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
67877-697-01Chlorthalidone100 in 1 BOTTLETABLET1007
67877-697-10Chlorthalidone1000 in 1 BOTTLETABLET10007
67877-697-33Chlorthalidone1 in 1 CARTONTABLET17
67877-697-33Chlorthalidone10 in 1 BLISTER PACKTABLET107
67877-697-38Chlorthalidone10 in 1 CARTONTABLET107
67877-697-38Chlorthalidone10 in 1 BLISTER PACKTABLET107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-697-01EA - Each67877-697e644ff4a-aa11-4ac1-b7ed-0c11a41e60c512020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-697CHLORTHALIDONE TABLET [ASCEND LABORATORIES, LLC]7Current NDC, Legacy NDC, 6 package rows20250425_d104583e-e983-4230-b6d1-4455ee1060a5.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChlorthalidoneCHLORTHALIDONEREMEDYREPACK INC.7d8e26e6-7314-4799-b137-934926d343b02026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213412
application number: ANDA213412
ChlorthalidoneCHLORTHALIDONEA-S Medication Solutions583992c2-b789-4267-9a8f-c1ee5db3f29f2026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213412
application number: ANDA213412
ChlorthalidoneCHLORTHALIDONEA-S Medication Solutions7d09c992-22f7-41e1-a836-380712f242c02025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213412
application number: ANDA213412
ChlorthalidoneCHLORTHALIDONEPreferred Pharmaceuticals Inc.d61367af-530b-4e5e-8e71-11c93f75ecf12025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213412
application number: ANDA213412
ChlorthalidoneCHLORTHALIDONEDirect_Rx401ae38b-2eb8-c9fc-e063-6294a90af2202025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213412
application number: ANDA213412
ChlorthalidoneCHLORTHALIDONEBryant Ranch Prepack165e5993-eb9d-4664-97dc-574ae5e0e9462025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213412
application number: ANDA213412
ChlorthalidoneCHLORTHALIDONEAscend Laboratories, LLCd104583e-e983-4230-b6d1-4455ee1060a52025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213412
application number: ANDA213412
ndc (product): 67877-697
ChlorthalidoneCHLORTHALIDONECoupler LLC2ccba8ab-4c34-af52-e063-6394a90a78d32025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213412
application number: ANDA213412
ChlorthalidoneCHLORTHALIDONEBryant Ranch Prepacke727d42f-e4e1-4cf6-9d7a-6ec2333bc6d12024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213412
application number: ANDA213412
ChlorthalidoneCHLORTHALIDONEBryant Ranch Prepacka1ab541b-7515-4888-b3e0-aca52875562d2024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213412
application number: ANDA213412
ChlorthalidoneCHLORTHALIDONEBryant Ranch Prepack98f4a14c-2863-4068-bd35-aaedcc8726802023-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213412
application number: ANDA213412
ChlorthalidoneCHLORTHALIDONEA-S Medication Solutionsc5796482-ad1f-437a-ae80-c288880f41002023-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213412
application number: ANDA213412

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197500chlorthalidone 50 MG Oral TabletPSNe727d42f-e4e1-4cf6-9d7a-6ec2333bc6d1104
197500chlorthalidone 50 MG Oral TabletSCDe727d42f-e4e1-4cf6-9d7a-6ec2333bc6d1104
197499chlorthalidone 25 MG Oral TabletPSNd104583e-e983-4230-b6d1-4455ee1060a57
197500chlorthalidone 50 MG Oral TabletPSN583992c2-b789-4267-9a8f-c1ee5db3f29f7
197500chlorthalidone 50 MG Oral TabletPSNd104583e-e983-4230-b6d1-4455ee1060a57
197499chlorthalidone 25 MG Oral TabletSCDd104583e-e983-4230-b6d1-4455ee1060a57
197500chlorthalidone 50 MG Oral TabletSCD583992c2-b789-4267-9a8f-c1ee5db3f29f7
197500chlorthalidone 50 MG Oral TabletSCDd104583e-e983-4230-b6d1-4455ee1060a57
197500chlorthalidone 50 MG Oral TabletPSN165e5993-eb9d-4664-97dc-574ae5e0e9462
197500chlorthalidone 50 MG Oral TabletSCD165e5993-eb9d-4664-97dc-574ae5e0e9462
197500chlorthalidone 50 MG Oral TabletPSN2ccba8ab-4c34-af52-e063-6394a90a78d31
197500chlorthalidone 50 MG Oral TabletSCD2ccba8ab-4c34-af52-e063-6394a90a78d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-697-0167877069701100 TABLET in 1 BOTTLE (67877-697-01) 100 tablet2020-02-130000-00-00NoNoCurrent
67877-697-10678770697101000 TABLET in 1 BOTTLE (67877-697-10) 1000 tablet2020-02-130000-00-00NoNoCurrent
67877-697-33678770697331 BLISTER PACK in 1 CARTON (67877-697-33) / 10 TABLET in 1 BLISTER PACK1 blister pack2020-02-130000-00-00NoNoCurrent
67877-697-386787706973810 BLISTER PACK in 1 CARTON (67877-697-38) / 10 TABLET in 1 BLISTER PACK10 blister pack2020-02-130000-00-00NoNoCurrent