FDA.reportPublic FDA data

CHLORPROMAZINE HYDROCHLORIDE

Product NDC
70518-3321
Requested package NDC
70518-3321-0
11-digit product format
705183321
Labeler code
70518
Product ID
70518-3321_d4dd2e80-32cc-6b13-e053-2a95a90aab2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORPROMAZINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209755
Marketing category
ANDA
Marketing start
2021-12-29
Marketing end
0000-00-00
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Phenothiazines [CS],Phenothiazine [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-332170518-3321-0DDiscontinued by firm2026-08-03

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3321-07051833210030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3321-0) 2021-12-290000-00-00NoNoCurrent