Home NDC 0409-2540 Hydromorphone Hydrochloride
Product NDC 0409-2540
11-digit product format 004092540
Labeler code 0409
Product ID 0409-2540_637c38f4-ec91-464c-aaed-34243c12cb33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROMORPHONE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hospira, Inc.
Application NDA200403
Marketing category NDA
Marketing start 2011-12-01
Marketing end 0000-00-00
Substance HYDROMORPHONE HYDROCHLORIDE
Active strength 4 mg/mL
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2021-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0409-2540-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0409-2540-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0409-2540-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0409-2540-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0409-2540-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0409-2540-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0409-2540-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0409-2540-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0409-2540-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0409-2540-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0409-2540-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0409-2540-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N200403-001 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2011-12-01 N200403-002 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2011-12-01 N200403-003 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE / INJECTION AP 2011-12-01 N200403-004 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION 2022-06-13 N200403-005 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 0.25MG/0.5ML INJECTABLE / INJECTION 2023-03-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 5 · 179 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 N200403-001 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2011-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200403-002 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2011-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200403-003 HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE / INJECTION AP 2011-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200403-004 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION 2022-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200403-005 HYDROMORPHONE HYDROCHLORIDE 0.25MG/0.5ML INJECTABLE / INJECTION 2023-03-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N200403-001 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2011-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200403-002 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2011-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200403-003 HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE / INJECTION AP 2011-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200403-004 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION 2022-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200403-005 HYDROMORPHONE HYDROCHLORIDE 0.25MG/0.5ML INJECTABLE / INJECTION 2023-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200403-001 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2011-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200403-002 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2011-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200403-003 HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE / INJECTION AP 2011-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200403-004 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION 2022-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200403-005 HYDROMORPHONE HYDROCHLORIDE 0.25MG/0.5ML INJECTABLE / INJECTION 2023-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N200403-001 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2011-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200403-002 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2011-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200403-003 HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE / INJECTION AP 2011-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200403-004 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION 2022-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200403-005 HYDROMORPHONE HYDROCHLORIDE 0.25MG/0.5ML INJECTABLE / INJECTION 2023-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200403-001 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2011-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200403-002 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2011-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200403-003 HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE / INJECTION AP 2011-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200403-004 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION 2022-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200403-005 HYDROMORPHONE HYDROCHLORIDE 0.25MG/0.5ML INJECTABLE / INJECTION 2023-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200403-001 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2011-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200403-002 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2011-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200403-003 HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE / INJECTION AP 2011-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200403-004 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION 2022-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200403-005 HYDROMORPHONE HYDROCHLORIDE 0.25MG/0.5ML INJECTABLE / INJECTION 2023-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200403-001 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2011-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200403-002 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2011-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200403-003 HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE / INJECTION AP 2011-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200403-004 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION 2022-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200403-005 HYDROMORPHONE HYDROCHLORIDE 0.25MG/0.5ML INJECTABLE / INJECTION 2023-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200403-001 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2011-12-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200403-002 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2011-12-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200403-003 HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE / INJECTION AP 2011-12-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200403-004 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION 2022-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200403-005 HYDROMORPHONE HYDROCHLORIDE 0.25MG/0.5ML INJECTABLE / INJECTION 2023-03-03 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-2540-01 Hydromorphone Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 33 0409-2540-11 Hydromorphone Hydrochloride 1 mL in 1 AMPULE INJECTION, SOLUTION 1 33
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.] 12 HYDROMORPHONE ACTIVE MOIETY Q812464R06 HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 LACTIC ACID, UNSPECIFIED FORM INACTIVE INGREDIENT 33X04XA5AT HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM LACTATE INACTIVE INGREDIENT TU7HW0W0QT HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-2540 HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 30 Legacy NDC, 2 package rows 20241206_e9c9ef18-7dfc-4322-b2fc-29b934c30f8b.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 Status 0409-2540-01 00409254001 10 in 1 CARTON Historical 0409-2540-11 00409254011 1 mL in 1 AMPULE 1 ml Historical