Home NDC 0409-2634 Hydromorphone Hydrochloride
Product NDC 0409-2634
11-digit product format 004092634
Labeler code 0409
Product ID 0409-2634_50886ad5-eeca-4fe7-beb0-01305f92c65d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydromorphone Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hospira, Inc.
Application ANDA078591
Marketing category ANDA
Marketing start 2008-07-31
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 2027-12-31
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 A078591-001 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078591-001 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 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078591-001 HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2008-06-17 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 10 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 1724338 Internal RxNorm lookup 1724340 Internal RxNorm lookup 1724341 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 0409-2634-01 Hydromorphone Hydrochloride 10 in 1 BOX INJECTION, SOLUTION 10 25 0409-2634-05 Hydromorphone Hydrochloride 10 in 1 BOX INJECTION, SOLUTION 10 25 0409-2634-10 Hydromorphone Hydrochloride 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 25 0409-2634-25 Hydromorphone Hydrochloride 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 25 0409-2634-50 Hydromorphone Hydrochloride 1 in 1 BOX INJECTION, SOLUTION 1 25 0409-2634-50 Hydromorphone Hydrochloride 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROMORPHONE HYDROCHLORIDE ACTIVE INGREDIENT L960UP2KRW HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 HYDROMORPHONE ACTIVE MOIETY Q812464R06 HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-2634 HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 24 Current NDC, Legacy NDC, 6 package rows 20250508_3832ede8-d3fc-455d-ecab-3b77be5869f5.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 · 2 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 0409-2634-01 00409263401 10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2634-10) 2008-08-08 0000-00-00 No No Current 0409-2634-05 00409263405 10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2634-25) 2008-08-07 0000-00-00 No No Current 0409-2634-10 00409263410 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 0409-2634-25 00409263425 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 0409-2634-50 00409263450 1 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-50) / 50 mL in 1 VIAL, SINGLE-DOSE 2008-07-31 0000-00-00 No No Current