Home NDC 0517-9702-25 Droperidol
Product NDC 0517-9702
Requested package NDC 0517-9702-25
11-digit product format 005179702
Labeler code 0517
Product ID 0517-9702_8bcdfec0-1df7-413d-82c1-ac564d18aaa0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Droperidol
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler American Regent, Inc.
Application ANDA072123
Marketing category ANDA
Marketing start 1990-09-30
Substance DROPERIDOL
Active strength 2.5 mg/mL
Pharmacologic classes Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072123-001 DROPERIDOL DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP RS 1988-10-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072123-001 AP
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 2 · 43 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 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP RS 1988-10-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP RS 1988-10-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP RS 1988-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP RS 1988-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP RS 1988-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP RS 1988-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP RS 1988-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP RS 1988-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION RS 1988-10-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072123-001 DROPERIDOL 2.5MG/ML INJECTABLE / INJECTION AP 1988-10-24 f41ea6bd6efb…
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 Droperidol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DROPERIDOL 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O9U0F09D5X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 282485 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 0517-9702-25 Droperidol 25 in 1 TRAY INJECTION, SOLUTION 25 8 0517-9702-25 Droperidol 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DROPERIDOL ACTIVE INGREDIENT O9U0F09D5X DROPERIDOL INJECTION, SOLUTION [AMERICAN REGENT, INC.] 3 DROPERIDOL ACTIVE MOIETY O9U0F09D5X DROPERIDOL INJECTION, SOLUTION [AMERICAN REGENT, INC.] 3 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT DROPERIDOL INJECTION, SOLUTION [AMERICAN REGENT, INC.] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I DROPERIDOL INJECTION, SOLUTION [AMERICAN REGENT, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R DROPERIDOL INJECTION, SOLUTION [AMERICAN REGENT, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-9702 DROPERIDOL INJECTION, SOLUTION [AMERICAN REGENT, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20230321_147e033d-d997-4ef6-8bb5-a9ba372590b2.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 Marketing start Marketing end Sample Exclude flag Status 0517-9702-25 00517970225 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9702-25) / 2 mL in 1 VIAL, SINGLE-DOSE 1990-09-30 0000-00-00 No No Current