Home NDC 68083-138 Haloperidol Decanoate
Product NDC 68083-138
11-digit product format 680830138
Labeler code 68083
Product ID 68083-138_da8f2d81-a122-4fe4-8f43-f2fe611d69c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol Decanoate
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Gland Pharma Limited
Application ANDA205241
Marketing category ANDA
Marketing start 2017-01-16
Substance HALOPERIDOL DECANOATE
Active strength 100 mg/mL
Pharmacologic classes Typical Antipsychotic [EPC]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205241-001 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 A205241-002 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
Product history page 1 of 3 · 84 observed 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 2026-08-18 06:07:40 2026-07 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205241-001 HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205241-002 HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION AO 2017-05-12 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Haloperidol Decanoate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HALOPERIDOL DECANOATE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AC20PJ4101 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859867 Internal RxNorm lookup 859871 Internal RxNorm lookup 1719803 Internal RxNorm lookup 1719862 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68083-138-02 Haloperidol Decanoate 5 mL in 1 VIAL INJECTION 5 14 68083-138-02 Haloperidol Decanoate 1 in 1 CARTON INJECTION 1 14 68083-138-10 Haloperidol Decanoate 10 in 1 CARTON INJECTION 10 14 68083-138-10 Haloperidol Decanoate 1 mL in 1 VIAL INJECTION 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-138 HALOPERIDOL DECANOATE INJECTION [GLAND PHARMA LIMITED] 12 Current NDC, Legacy NDC, 4 package rows 20250223_1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68083-138-02 68083013802 1 VIAL in 1 CARTON (68083-138-02) / 5 mL in 1 VIAL 1 vial 2017-01-16 0000-00-00 No No Current 68083-138-10 68083013810 10 VIAL in 1 CARTON (68083-138-10) / 1 mL in 1 VIAL 10 vial 2017-01-16 0000-00-00 No No Current