FDA.reportPublic FDA data

Chlorpromazine Hydrochloride

Product NDC
72205-190
11-digit product format
722050190
Labeler code
72205
Product ID
72205-190_c0c5f94c-5f4d-43db-8cc2-ffc8a45b64cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorpromazine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA216092
Marketing category
ANDA
Marketing start
2026-01-26
Substance
CHLORPROMAZINE HYDROCHLORIDE
Active strength
25 mg/mL
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216092-001CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONAP2026-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216092-001AP

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
2026-09-14 22:38:342026-08A216092-001CHLORPROMAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONAP2026-01-2684e616aacf4f…
2026-08-18 06:07:402026-07A216092-001CHLORPROMAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONAP2026-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216092-001CHLORPROMAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONAP2026-01-26011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216092-001CHLORPROMAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONAP2026-01-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216092-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A216092-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216092-001AP1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216092-001AP1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPROMAZINE HYDROCHLORIDE25 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1730076Internal RxNorm lookup
1730078Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0c5f94c-5f4d-43db-8cc2-ffc8a45b64cfAvailable 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
72205-190-01Chlorpromazine Hydrochloride1 mL in 1 VIALINJECTION11
72205-190-25Chlorpromazine Hydrochloride25 in 1 CARTONINJECTION251

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 HYDROCHLORIDENovadoz Pharmaceuticals LLCc0c5f94c-5f4d-43db-8cc2-ffc8a45b64cf2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216092
application number: ANDA216092
ndc (product): 72205-190

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1730076chlorproMAZINE HCl 25 MG in 1 ML InjectionPSNc0c5f94c-5f4d-43db-8cc2-ffc8a45b64cf1
1730078chlorproMAZINE HCl 50 MG in 2 ML InjectionPSNc0c5f94c-5f4d-43db-8cc2-ffc8a45b64cf1
17300761 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCDc0c5f94c-5f4d-43db-8cc2-ffc8a45b64cf1
17300782 ML chlorpromazine hydrochloride 25 MG/ML InjectionSCDc0c5f94c-5f4d-43db-8cc2-ffc8a45b64cf1
1730076chlorpromazine HCl 25 MG per 1 ML InjectionSYc0c5f94c-5f4d-43db-8cc2-ffc8a45b64cf1
1730078chlorpromazine HCl 50 MG per 2 ML InjectionSYc0c5f94c-5f4d-43db-8cc2-ffc8a45b64cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-190-01722050190011 mL in 1 VIAL1 mlHistorical
72205-190-257220501902525 VIAL in 1 CARTON (72205-190-25) / 1 mL in 1 VIAL (72205-190-01) 25 vial2026-02-02NoNoCurrent