Home NDC 17478-540-50 Hydromorphone Hydrochloride
Product NDC 17478-540
Requested package NDC 17478-540-50
11-digit product format 174780540
Labeler code 17478
Product ID 17478-540_dca637ff-97ef-4583-baeb-bb4096591ba1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydromorphone Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Akorn
Application ANDA078228
Marketing category ANDA
Marketing start 2010-05-15
Marketing end 0000-00-00
Substance HYDROMORPHONE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A078228-001 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078228-001 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 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078228-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2010-04-14 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 17478-540-01 2024-01-30 C162847 48780-1 1030e365-0336-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION (HPF) safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION (HPF). HYDROMORPHONE HYDROCLORIDE injection, USP [high potency formulation (HPF)], for intravenous, intramuscular, or subcutaneous use Initial U.S. Approval: 1984 17478-540-05 2024-01-30 C162847 48780-1 1030e365-0336-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION (HPF) safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION (HPF). HYDROMORPHONE HYDROCLORIDE injection, USP [high potency formulation (HPF)], for intravenous, intramuscular, or subcutaneous use Initial U.S. Approval: 1984 17478-540-50 2024-01-30 C162847 48780-1 1030e365-0336-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION (HPF) safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION (HPF). HYDROMORPHONE HYDROCLORIDE injection, USP [high potency formulation (HPF)], for intravenous, intramuscular, or subcutaneous use Initial U.S. Approval: 1984
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17478-540-01 Hydromorphone Hydrochloride 10 in 1 CARTON INJECTION 10 12 17478-540-01 Hydromorphone Hydrochloride 1 mL in 1 AMPULE INJECTION 1 12 17478-540-05 Hydromorphone Hydrochloride 5 mL in 1 AMPULE INJECTION 5 12 17478-540-05 Hydromorphone Hydrochloride 10 in 1 CARTON INJECTION 10 12 17478-540-50 Hydromorphone Hydrochloride 50 mL in 1 VIAL INJECTION 50 12 17478-540-50 Hydromorphone Hydrochloride 1 in 1 CARTON INJECTION 1 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-540 HYDROMORPHONE HYDROCHLORIDE INJECTION [AKORN] 12 Legacy NDC, 6 package rows 20220914_4d33b072-0755-4b8c-9558-2551306756a3.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 17478-540-50 17478054050 1 VIAL in 1 CARTON (17478-540-50) > 50 mL in 1 VIAL 1 vial 2010-05-15 0000-00-00 No No Current