FDA.reportPublic FDA data

CHLORPROMAZINE HYDROCHLORIDE

Product NDC
69238-1054
11-digit product format
692381054
Labeler code
69238
Product ID
69238-1054_9e50c657-1fae-40c2-af7e-e3c389dd5a6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORPROMAZINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209755
Marketing category
ANDA
Marketing start
2018-09-12
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209755-001CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2018-09-10
A209755-002CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2018-09-10
A209755-003CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2018-09-10
A209755-004CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2018-09-10
A209755-005CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2018-09-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A209755-001AB
A209755-002AB
A209755-003AB
A209755-004AB
A209755-005AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209755-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2018-09-10a50c72e98297…
2026-08-01 22:54:322026-06A209755-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2018-09-10a50c72e98297…
2026-08-01 22:54:322026-06A209755-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2018-09-10a50c72e98297…
2026-08-01 22:54:322026-06A209755-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2018-09-10a50c72e98297…
2026-08-01 22:54:322026-06A209755-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2018-09-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209755-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209755-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A209755-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A209755-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A209755-005AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCaa086a21-de85-4b03-af58-49b70acf8cf02026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209755
application number: ANDA209755
ndc (product): 69238-1054
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAK9e8cebc0-7fcf-dca8-e053-2a95a90a33692026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209755
application number: ANDA209755
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health Packagingd43718e5-66d7-44f9-9fc8-80d38d3e41ce2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209755
application number: ANDA209755

Additional Listing Data#

Finished product
Yes
Brand name base
CHLORPROMAZINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPROMAZINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9WP59609J6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
991039Internal RxNorm lookup
991044Internal RxNorm lookup
991188Internal RxNorm lookup
991194Internal RxNorm lookup
991336Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa086a21-de85-4b03-af58-49b70acf8cf0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4907e598-fa92-6444-8b2a-22992506f30aProduct name720260202
78470689-2901-bec5-3fa3-182378bb1540Product name320250124
a347b2b0-0f41-4d16-ac0d-358db7d523f1Product name120220110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1054-1CHLORPROMAZINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1054-1EA - Each69238-10544c57f430-2e52-4fd9-9c37-ad6c413a92a712018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1054CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]7Current NDC, Legacy NDC, 1 package rows20231230_aa086a21-de85-4b03-af58-49b70acf8cf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991039chlorproMAZINE HCl 10 MG Oral TabletPSNaa086a21-de85-4b03-af58-49b70acf8cf08
991044chlorproMAZINE HCl 100 MG Oral TabletPSNaa086a21-de85-4b03-af58-49b70acf8cf08
991188chlorproMAZINE HCl 200 MG Oral TabletPSNaa086a21-de85-4b03-af58-49b70acf8cf08
991194chlorproMAZINE HCl 25 MG Oral TabletPSNaa086a21-de85-4b03-af58-49b70acf8cf08
991336chlorproMAZINE HCl 50 MG Oral TabletPSNaa086a21-de85-4b03-af58-49b70acf8cf08
991039chlorpromazine hydrochloride 10 MG Oral TabletSCDaa086a21-de85-4b03-af58-49b70acf8cf08
991044chlorpromazine hydrochloride 100 MG Oral TabletSCDaa086a21-de85-4b03-af58-49b70acf8cf08
991188chlorpromazine hydrochloride 200 MG Oral TabletSCDaa086a21-de85-4b03-af58-49b70acf8cf08
991194chlorpromazine hydrochloride 25 MG Oral TabletSCDaa086a21-de85-4b03-af58-49b70acf8cf08
991336chlorpromazine hydrochloride 50 MG Oral TabletSCDaa086a21-de85-4b03-af58-49b70acf8cf08
991039chlorproMAZINE HCl 10 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991044chlorproMAZINE HCl 100 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991188chlorproMAZINE HCl 200 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991194chlorproMAZINE HCl 25 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991336chlorproMAZINE HCl 50 MG Oral TabletPSN9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991039chlorpromazine hydrochloride 10 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991044chlorpromazine hydrochloride 100 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991188chlorpromazine hydrochloride 200 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991194chlorpromazine hydrochloride 25 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991336chlorpromazine hydrochloride 50 MG Oral TabletSCD9e8cebc0-7fcf-dca8-e053-2a95a90a33696
991039chlorproMAZINE HCl 10 MG Oral TabletPSNd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991044chlorproMAZINE HCl 100 MG Oral TabletPSNd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991188chlorproMAZINE HCl 200 MG Oral TabletPSNd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991194chlorproMAZINE HCl 25 MG Oral TabletPSNd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991336chlorproMAZINE HCl 50 MG Oral TabletPSNd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991039chlorpromazine hydrochloride 10 MG Oral TabletSCDd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991044chlorpromazine hydrochloride 100 MG Oral TabletSCDd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991188chlorpromazine hydrochloride 200 MG Oral TabletSCDd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991194chlorpromazine hydrochloride 25 MG Oral TabletSCDd43718e5-66d7-44f9-9fc8-80d38d3e41ce5
991336chlorpromazine hydrochloride 50 MG Oral TabletSCDd43718e5-66d7-44f9-9fc8-80d38d3e41ce5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1054-169238105401100 TABLET, FILM COATED in 1 BOTTLE (69238-1054-1) 2018-09-120000-00-00NoNoCurrent