Home NDC 0641-6151 Hydromorphone Hydrochloride
Product NDC 0641-6151
11-digit product format 006416151
Labeler code 0641
Product ID 0641-6151_4c244852-0374-445f-8419-72e8ec359faa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydromorphone Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA202159
Marketing category ANDA
Marketing start 2018-07-01
Substance HYDROMORPHONE HYDROCHLORIDE
Active strength 2 mg/mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
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 1 .
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 A202159-001 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202159-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202159-001 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2018-04-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 2 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1724276 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 0641-6151-01 Hydromorphone Hydrochloride 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 8 0641-6151-25 Hydromorphone Hydrochloride 25 in 1 CARTON INJECTION 25 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6151 HYDROMORPHONE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240410_67e79859-4efc-4ea7-8211-cadf746bc864.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 0641-6151-01 00641615101 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 0641-6151-25 00641615125 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6151-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6151-01) 2018-07-01 0000-00-00 No No Current