Home NDC 27241-265 Haloperidol
Product NDC 27241-265
11-digit product format 272410265
Labeler code 27241
Product ID 27241-265_3af25358-362b-4046-98c9-1c12eb623e02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol
Dosage form TABLET
Route ORAL
Labeler Ajanta Pharma USA Inc.
Application ANDA218210
Marketing category ANDA
Marketing start 2026-09-14
Substance HALOPERIDOL
Active strength 1 mg/1
Pharmacologic classes Typical Antipsychotic [EPC]
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 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218210-001 HALOPERIDOL HALOPERIDOL 0.5MG TABLET / ORAL AB 2026-09-14 A218210-002 HALOPERIDOL HALOPERIDOL 1MG TABLET / ORAL AB 2026-09-14 A218210-003 HALOPERIDOL HALOPERIDOL 2MG TABLET / ORAL AB 2026-09-14 A218210-004 HALOPERIDOL HALOPERIDOL 5MG TABLET / ORAL AB 2026-09-14 A218210-005 HALOPERIDOL HALOPERIDOL 10MG TABLET / ORAL AB 2026-09-14 A218210-006 HALOPERIDOL HALOPERIDOL 20MG TABLET / ORAL AB 2026-09-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A218210-001 HALOPERIDOL 0.5MG TABLET / ORAL AB 2026-09-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A218210-002 HALOPERIDOL 1MG TABLET / ORAL AB 2026-09-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A218210-003 HALOPERIDOL 2MG TABLET / ORAL AB 2026-09-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A218210-004 HALOPERIDOL 5MG TABLET / ORAL AB 2026-09-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A218210-005 HALOPERIDOL 10MG TABLET / ORAL AB 2026-09-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A218210-006 HALOPERIDOL 20MG TABLET / ORAL AB 2026-09-14 c2088c7a36db…
Observed Orange Book normalized TE history# 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 Haloperidol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HALOPERIDOL 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J6292F8L3D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197754 Internal RxNorm lookup 310670 Internal RxNorm lookup 310671 Internal RxNorm lookup 310672 Internal RxNorm lookup 314034 Internal RxNorm lookup 314035 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 27241-265-01 27241026501 100 TABLET in 1 BOTTLE (27241-265-01) 100 tablet 2026-09-14 No No Current