Chlorpromazine Hydrochloride

Product NDC
68462-862
11-digit product format
684620862
Labeler code
68462
Product ID
68462-862_440a4208-83cc-4ffa-952c-d9c0745c342a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA212144
Marketing category
ANDA
Marketing start
2021-03-23
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212144-001CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-23
A212144-002CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2021-03-23
A212144-003CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2021-03-23
A212144-004CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2021-03-23
A212144-005CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2021-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212144-001AB
A212144-002AB
A212144-003AB
A212144-004AB
A212144-005AB

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.

Product history page 1 of 5 · 170 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212144-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212144-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2021-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212144-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2021-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212144-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2021-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212144-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2021-03-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212144-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212144-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2021-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212144-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2021-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212144-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2021-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212144-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2021-03-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A212144-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212144-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2021-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212144-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2021-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212144-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2021-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212144-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2021-03-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212144-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212144-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2021-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212144-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2021-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212144-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2021-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212144-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2021-03-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212144-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212144-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2021-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212144-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2021-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212144-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2021-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212144-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2021-03-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212144-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212144-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2021-03-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212144-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2021-03-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212144-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2021-03-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212144-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2021-03-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212144-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212144-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2021-03-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212144-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2021-03-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212144-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2021-03-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212144-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2021-03-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212144-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212144-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2021-03-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212144-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2021-03-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212144-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2021-03-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212144-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2021-03-235bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 170 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212144-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212144-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212144-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212144-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212144-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212144-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212144-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212144-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212144-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212144-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212144-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212144-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212144-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212144-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212144-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212144-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212144-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212144-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212144-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212144-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212144-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212144-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212144-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212144-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212144-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212144-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212144-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212144-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212144-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212144-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212144-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212144-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212144-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212144-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212144-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212144-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212144-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212144-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212144-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212144-005AB15bbf6a4d5a75…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2021-12-28 21:50 UTC2021-12A212144-001CGT2021-09-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A212144-002CGT2021-09-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A212144-003CGT2021-09-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A212144-004CGT2021-09-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A212144-005CGT2021-09-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212144-001CGT2021-09-2087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212144-002CGT2021-09-2087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212144-003CGT2021-09-2087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212144-004CGT2021-09-2087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212144-005CGT2021-09-2087673890dc5c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPROMAZINE HYDROCHLORIDE25 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
a6065ac5-a111-449b-b51b-8bc2907d1ddbAvailable 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
68462-862-01Chlorpromazine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
68462-862-10Chlorpromazine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-862-01EA - Each68462-862bf28e6db-af67-4876-bbfb-a5d2d8b9934e12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-862CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]4Current NDC, Legacy NDC, 2 package rows20240516_a6065ac5-a111-449b-b51b-8bc2907d1ddb.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
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USAa6065ac5-a111-449b-b51b-8bc2907d1ddb2023-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212144
application number: ANDA212144
ndc (product): 68462-862

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991039chlorproMAZINE HCl 10 MG Oral TabletPSNa6065ac5-a111-449b-b51b-8bc2907d1ddb4
991044chlorproMAZINE HCl 100 MG Oral TabletPSNa6065ac5-a111-449b-b51b-8bc2907d1ddb4
991188chlorproMAZINE HCl 200 MG Oral TabletPSNa6065ac5-a111-449b-b51b-8bc2907d1ddb4
991194chlorproMAZINE HCl 25 MG Oral TabletPSNa6065ac5-a111-449b-b51b-8bc2907d1ddb4
991336chlorproMAZINE HCl 50 MG Oral TabletPSNa6065ac5-a111-449b-b51b-8bc2907d1ddb4
991039chlorpromazine hydrochloride 10 MG Oral TabletSCDa6065ac5-a111-449b-b51b-8bc2907d1ddb4
991044chlorpromazine hydrochloride 100 MG Oral TabletSCDa6065ac5-a111-449b-b51b-8bc2907d1ddb4
991188chlorpromazine hydrochloride 200 MG Oral TabletSCDa6065ac5-a111-449b-b51b-8bc2907d1ddb4
991194chlorpromazine hydrochloride 25 MG Oral TabletSCDa6065ac5-a111-449b-b51b-8bc2907d1ddb4
991336chlorpromazine hydrochloride 50 MG Oral TabletSCDa6065ac5-a111-449b-b51b-8bc2907d1ddb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-862-0168462086201100 TABLET, FILM COATED in 1 BOTTLE (68462-862-01) 2021-03-230000-00-00NoNoCurrent
68462-862-10684620862101000 TABLET, FILM COATED in 1 BOTTLE (68462-862-10) 2021-03-230000-00-00NoNoCurrent