Disulfiram

Product NDC
62135-432
11-digit product format
621350432
Labeler code
62135
Product ID
62135-432_06fe77f7-a1e1-f066-e063-6294a90a7653
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Disulfiram
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA091563
Marketing category
ANDA
Marketing start
2012-12-31
Substance
DISULFIRAM
Active strength
500 mg/1
Pharmacologic classes
Acetyl Aldehyde Dehydrogenase Inhibitors [MoA], Aldehyde Dehydrogenase Inhibitor [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
A091563-001DISULFIRAMDISULFIRAM250MGTABLET / ORALAB2012-12-31
A091563-002DISULFIRAMDISULFIRAM500MGTABLET / ORALABRS2012-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091563-001AB
A091563-002AB

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 UTC2026-02A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091563-002DISULFIRAM500MGTABLET / ORALABRS2012-12-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091563-002DISULFIRAM500MGTABLET / ORALAB2012-12-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091563-002DISULFIRAM500MGTABLET / ORALAB2012-12-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091563-002DISULFIRAM500MGTABLET / ORALAB2012-12-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091563-002DISULFIRAM500MGTABLET / ORALAB2012-12-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091563-002DISULFIRAM500MGTABLET / ORALAB2012-12-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091563-001DISULFIRAM250MGTABLET / ORALAB2012-12-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A091563-002DISULFIRAM500MGTABLET / ORALAB2012-12-31782e0a99824c…

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 UTC2026-02A091563-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091563-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091563-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091563-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091563-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091563-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091563-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091563-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091563-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091563-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091563-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091563-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091563-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091563-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091563-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091563-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091563-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091563-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091563-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091563-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091563-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091563-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091563-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091563-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091563-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091563-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091563-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091563-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091563-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091563-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091563-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091563-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091563-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091563-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091563-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091563-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091563-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091563-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091563-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091563-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Disulfiram
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DISULFIRAM500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TR3MLJ1UAIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197623Internal RxNorm lookup
197624Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
07abe950-3565-418c-8086-b804406a8c87Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1abf4562-030c-45f5-a6c4-ba508de7c203Product name120150413

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-432-30Disulfiram30 in 1 BOTTLETABLET307
62135-432-90Disulfiram90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-432-30EA - Each62135-4328df2c56e-116a-43be-8219-fbb2b0aab8ec12021-12-08
62135-432-90EA - Each62135-4327a4efe62-dbb9-4037-9801-eebef1e26c0112021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-432DISULFIRAM TABLET [CHARTWELL RX, LLC]7Current NDC, Legacy NDC, 2 package rows20231006_07abe950-3565-418c-8086-b804406a8c87.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DisulfiramDISULFIRAMChartwell RX, LLC07abe950-3565-418c-8086-b804406a8c872023-10-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091563
application number: ANDA091563
ndc (product): 62135-432

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197623disulfiram 250 MG Oral TabletPSN07abe950-3565-418c-8086-b804406a8c877
197624disulfiram 500 MG Oral TabletPSN07abe950-3565-418c-8086-b804406a8c877
197623disulfiram 250 MG Oral TabletSCD07abe950-3565-418c-8086-b804406a8c877
197624disulfiram 500 MG Oral TabletSCD07abe950-3565-418c-8086-b804406a8c877

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-432-306213504323030 TABLET in 1 BOTTLE (62135-432-30) 30 tablet2021-11-180000-00-00NoNoCurrent
62135-432-906213504329090 TABLET in 1 BOTTLE (62135-432-90) 90 tablet2021-11-180000-00-00NoNoCurrent