Chlorpromazine Hydrochloride

Product NDC
70518-3549
11-digit product format
705183549
Labeler code
70518
Product ID
70518-3549_4a924606-27bd-8424-e063-6394a90a0fb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA214827
Marketing category
ANDA
Marketing start
2022-10-03
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-354970518-3549-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-354970518-3549-1DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214827-001CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2022-01-27
A214827-002CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2022-01-27
A214827-003CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2022-01-27
A214827-004CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2022-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A214827-001AB
A214827-002AB
A214827-003AB
A214827-004AB

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 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214827-001CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2022-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214827-002CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2022-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214827-003CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2022-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214827-004CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2022-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214827-001CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2022-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214827-002CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2022-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214827-003CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2022-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214827-004CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2022-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A214827-001CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2022-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214827-002CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2022-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214827-003CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2022-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214827-004CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2022-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214827-001CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2022-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214827-002CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2022-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214827-003CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2022-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214827-004CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2022-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214827-001CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2022-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214827-002CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2022-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214827-003CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2022-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214827-004CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2022-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214827-001CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2022-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214827-002CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2022-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214827-003CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2022-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214827-004CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2022-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214827-001CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2022-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214827-002CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2022-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214827-003CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2022-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214827-004CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2022-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214827-001CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2022-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214827-002CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2022-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214827-003CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2022-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214827-004CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2022-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214827-001CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2022-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214827-002CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2022-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214827-003CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2022-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214827-004CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2022-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214827-001CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2022-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A214827-002CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2022-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A214827-003CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2022-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A214827-004CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2022-01-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214827-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214827-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214827-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214827-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214827-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214827-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214827-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214827-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214827-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214827-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214827-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214827-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214827-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214827-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214827-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214827-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214827-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214827-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214827-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214827-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214827-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214827-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214827-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214827-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214827-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214827-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214827-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214827-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214827-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214827-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214827-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214827-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214827-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214827-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214827-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214827-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214827-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214827-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214827-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214827-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorpromazine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPROMAZINE HYDROCHLORIDE50 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
c2a38be8-43e6-4a56-9556-fe3dad412b82Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a347b2b0-0f41-4d16-ac0d-358db7d523f1Product name120220110
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3549-0Chlorpromazine Hydrochloride30 in 1 BLISTER PACKTABLET, SUGAR COATED305
70518-3549-1Chlorpromazine Hydrochloride100 in 1 BOXTABLET, SUGAR COATED1005
70518-3549-2Chlorpromazine Hydrochloride1 in 1 POUCHTABLET, SUGAR COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3549CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 3 package rows20240420_c2a38be8-43e6-4a56-9556-fe3dad412b82.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEAmerican Health Packaging85ab0b93-c716-4889-87db-9e76e75df7c72026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214827
application number: ANDA214827
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.d3b09b67-e8da-450d-8a52-b3c40605de262026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214827
application number: ANDA214827
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.b8137906-946c-455d-87c0-0e130cd9266f2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214827
application number: ANDA214827
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.2122d619-3f5b-48f6-8f0b-7693199abbdb2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214827
application number: ANDA214827
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.c2a38be8-43e6-4a56-9556-fe3dad412b822026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214827
application number: ANDA214827
ndc (product): 70518-3549
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDECoupler LLC472e9a45-4060-3b2a-e063-6294a90a716a2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214827
application number: ANDA214827
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDECoupler LLC35a743a1-5354-2c50-e063-6394a90a15f92025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214827
application number: ANDA214827
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDENovadoz Pharmaceuticals LLC315ce03f-d9f8-4f3a-9e83-922747430c232022-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214827
application number: ANDA214827

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991336chlorproMAZINE HCl 50 MG Oral TabletPSNc2a38be8-43e6-4a56-9556-fe3dad412b825
991336chlorpromazine hydrochloride 50 MG Oral TabletSCDc2a38be8-43e6-4a56-9556-fe3dad412b825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3549-07051835490030 TABLET, SUGAR COATED in 1 BLISTER PACK (70518-3549-0) 2022-10-030000-00-00NoNoCurrent
70518-3549-170518354901100 POUCH in 1 BOX (70518-3549-1) / 1 TABLET, SUGAR COATED in 1 POUCH (70518-3549-2) 100 pouch2024-04-19NoNoCurrent
70518-3549-2705183549021 in 1 POUCHHistorical