Home NDC 0054-0386 Hydromorphone Hydrochloride
Product NDC 0054-0386
11-digit product format 000540386
Labeler code 0054
Product ID 0054-0386_4c3c8198-731d-4136-9222-01063f3364cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydromorphone hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA074653
Marketing category ANDA
Marketing start 2012-03-01
Substance HYDROMORPHONE HYDROCHLORIDE
Active strength 1 mg/mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
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 42 .
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 A074653-001 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074653-001 AA
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 · 42 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 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074653-001 HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 1998-07-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Hydromorphone Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROMORPHONE HYDROCHLORIDE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L960UP2KRW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 897657 Internal RxNorm lookup 897702 Internal RxNorm lookup 897710 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 0054-0386-63 Hydromorphone Hydrochloride 473 mL in 1 BOTTLE SOLUTION 473 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROMORPHONE HYDROCHLORIDE ACTIVE INGREDIENT L960UP2KRW HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 HYDROMORPHONE ACTIVE MOIETY Q812464R06 HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 LACTOSE INACTIVE INGREDIENT J2B2A4N98G HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 RASPBERRY INACTIVE INGREDIENT 4N14V5R27W HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 SACCHARIN SODIUM ANHYDROUS INACTIVE INGREDIENT I4807BK602 HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 SORBITOL INACTIVE INGREDIENT 506T60A25R HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0386 HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 19 Current NDC, Legacy NDC, 1 package rows 20240308_cc574063-6ede-4da7-82c4-7450c92b229b.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 0054-0386-63 00054038663 473 mL in 1 BOTTLE (0054-0386-63) 473 ml 2012-03-01 0000-00-00 No No Current