Home NDC 50458-253-03 Haldol Decanoate
Product NDC 50458-253
Requested package NDC 50458-253-03
11-digit product format 504580253
Labeler code 50458
Product ID 50458-253_fa5844a2-8722-442f-8724-f4fa90631af0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol Decanoate
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Janssen Pharmaceuticals, Inc.
Application NDA018701
Marketing category NDA
Marketing start 1986-01-14
Marketing end 0000-00-00
Substance HALOPERIDOL DECANOATE
Active strength 50 mg/mL
Pharmacologic classes Typical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N018701-001 HALDOL HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE / INJECTION RLD 1986-01-14 N018701-002 HALDOL HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE / INJECTION RLD 1997-01-31
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 · 86 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 2026-09-14 22:38:34 2026-08 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION RLD 1986-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION RLD 1997-01-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION RLD 1986-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION RLD 1997-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION RLD 1986-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION RLD 1997-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION RLD 1986-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION RLD 1997-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018701-001 HALDOL EQ 50MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1986-01-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018701-002 HALDOL EQ 100MG BASE/ML INJECTABLE / INJECTION AO RLD, RS 1997-01-31 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50458-253-01 Haldol Decanoate 1 mL in 1 AMPULE INJECTION 1 25 50458-253-01 Haldol Decanoate 10 in 1 BOX INJECTION 10 25 50458-253-03 Haldol Decanoate 3 in 1 BOX INJECTION 3 25 50458-253-03 Haldol Decanoate 1 mL in 1 AMPULE INJECTION 1 25
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50458-253 HALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.] 24 Legacy NDC, 4 package rows 20250131_af0159a8-dff5-449a-aa2b-a0c430081e21.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.
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 50458-253-03 50458025303 3 AMPULE in 1 BOX (50458-253-03) > 1 mL in 1 AMPULE 3 ampule 1986-01-14 0000-00-00 No No Current