Home NDC 0641-6259 Hydromorphone Hydrochloride
Product NDC 0641-6259
11-digit product format 006416259
Labeler code 0641
Product ID 0641-6259_08fdd324-f2ce-4a29-a6d1-fc88aa10b7ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydromorphone Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA216899
Marketing category ANDA
Marketing start 2024-04-26
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 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216899-001 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2024-02-09 A216899-002 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION AP 2024-02-09 A216899-003 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-02-09 A216899-004 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2024-02-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 72 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 A216899-001 HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2024-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216899-002 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION AP 2024-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216899-003 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216899-004 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2024-02-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216899-001 HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2024-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216899-002 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION AP 2024-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216899-003 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216899-004 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2024-02-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216899-001 HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2024-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216899-002 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION AP 2024-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216899-003 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216899-004 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2024-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216899-001 HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2024-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216899-002 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION AP 2024-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216899-003 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216899-004 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2024-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216899-001 HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2024-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216899-002 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION AP 2024-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216899-003 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216899-004 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2024-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216899-001 HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2024-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216899-002 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION AP 2024-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216899-003 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216899-004 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2024-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216899-001 HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2024-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216899-002 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION AP 2024-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216899-003 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216899-004 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2024-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216899-001 HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2024-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216899-002 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION AP 2024-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216899-003 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216899-004 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2024-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216899-001 HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2024-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216899-002 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION AP 2024-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216899-003 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216899-004 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2024-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216899-001 HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2024-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216899-002 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION AP 2024-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216899-003 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216899-004 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2024-02-09 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Observed Orange Book exclusivity history# 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 897756 Internal RxNorm lookup 897757 Internal RxNorm lookup 1433251 Internal RxNorm lookup 2277368 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 0641-6259-01 Hydromorphone Hydrochloride 1 mL in 1 SYRINGE INJECTION 1 3 0641-6259-10 Hydromorphone Hydrochloride 10 in 1 CARTON INJECTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6259 HYDROMORPHONE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 3 Current NDC, 2 package rows 20240509_31d5a37a-0e90-4e88-be14-75c877be9de2.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 Sample Exclude flag Status 0641-6259-01 00641625901 1 mL in 1 SYRINGE 1 ml Historical 0641-6259-10 00641625910 10 SYRINGE in 1 CARTON (0641-6259-10) / 1 mL in 1 SYRINGE (0641-6259-01) 10 syringe 2024-04-26 No No Current