Chlorpromazine

Product NDC
0615-1547
11-digit product format
006151547
Labeler code
0615
Product ID
0615-1547_4d95826c-dfb7-4752-86ea-54f4b83e04aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA080439
Marketing category
ANDA
Marketing start
1973-01-03
Marketing end
0000-00-00
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Phenothiazines [CS],Phenothiazine [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-1547DDiscontinued by firm2026-08-17
excluded packagepackage0615-15470615-1547-39DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-1547-39DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-1547-39DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-1547-39DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-1547-39DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-1547-39DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-1547-39DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-1547-39DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-1547-39DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-1547-39DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-1547-39DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-1547-39DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-1547-39DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0615-1547-39IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0615-1547-39IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0615-1547-39EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080439-001CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982
A080439-002CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982
A080439-003CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982
A080439-004CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982
A080439-005CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A080439-001CHLORPROMAZINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A080439-002CHLORPROMAZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A080439-003CHLORPROMAZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A080439-004CHLORPROMAZINE HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A080439-005CHLORPROMAZINE HYDROCHLORIDE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080439-001CHLORPROMAZINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080439-002CHLORPROMAZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080439-003CHLORPROMAZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080439-004CHLORPROMAZINE HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080439-005CHLORPROMAZINE HYDROCHLORIDE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080439-001CHLORPROMAZINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080439-002CHLORPROMAZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080439-003CHLORPROMAZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080439-004CHLORPROMAZINE HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080439-005CHLORPROMAZINE HYDROCHLORIDE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080439-001CHLORPROMAZINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080439-002CHLORPROMAZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080439-003CHLORPROMAZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080439-004CHLORPROMAZINE HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080439-005CHLORPROMAZINE HYDROCHLORIDE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080439-001CHLORPROMAZINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080439-002CHLORPROMAZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080439-003CHLORPROMAZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080439-004CHLORPROMAZINE HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080439-005CHLORPROMAZINE HYDROCHLORIDE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080439-001CHLORPROMAZINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080439-002CHLORPROMAZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080439-003CHLORPROMAZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080439-004CHLORPROMAZINE HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080439-005CHLORPROMAZINE HYDROCHLORIDE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080439-001CHLORPROMAZINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080439-002CHLORPROMAZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080439-003CHLORPROMAZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080439-004CHLORPROMAZINE HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080439-005CHLORPROMAZINE HYDROCHLORIDE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080439-001CHLORPROMAZINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080439-002CHLORPROMAZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080439-003CHLORPROMAZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080439-004CHLORPROMAZINE HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080439-005CHLORPROMAZINE HYDROCHLORIDE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19822680178bc6a6…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-1547-392021-04-09C16284748780-19d75b9d0-2eff-f424-e053-dadaa90a57ceChlorproMAZINE Hydrochloride Tablets, USP
0615-1547-392020-01-31C16284748780-19d75b9d0-2eff-f424-e053-dadaa90a57ceChlorproMAZINE Hydrochloride Tablets, USP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPROMAZINE HYDROCHLORIDEACTIVE INGREDIENT9WP59609J6CHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
CHLORPROMAZINEACTIVE MOIETYU42B7VYA4PCHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
POVIDONESINACTIVE INGREDIENTFZ989GH94ECHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5