Home NDC 0409-1312 Hydromorphone Hydrochloride
Product NDC 0409-1312
11-digit product format 004091312
Labeler code 0409
Product ID 0409-1312_766e302a-2d03-4d93-b237-2348b57ee517
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 2021-02-01
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 2027-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 RLD 2011-12-01 N200403-002 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD 2011-12-01 N200403-003 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-12-01 N200403-004 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION RLD 2022-06-13 N200403-005 HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 0.25MG/0.5ML INJECTABLE / INJECTION RLD 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 · 184 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 N200403-001 HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP RLD 2011-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200403-002 HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD 2011-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200403-003 HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200403-004 HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION RLD 2022-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200403-005 HYDROMORPHONE HYDROCHLORIDE 0.25MG/0.5ML INJECTABLE / INJECTION RLD 2023-03-03 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 897756 Internal RxNorm lookup 897757 Internal RxNorm lookup 1433251 Internal RxNorm lookup 1724383 Internal RxNorm lookup 1724644 Internal RxNorm lookup 2675350 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 0409-1312-03 Hydromorphone Hydrochloride 1 mL in 1 CARTRIDGE INJECTION, SOLUTION 1 33 0409-1312-30 Hydromorphone Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 33 0409-1312-16 Hydromorphone Hydrochloride 1 mL in 1 SYRINGE INJECTION, SOLUTION 1 12 0409-1312-36 Hydromorphone Hydrochloride 10 in 1 CELLO PACK INJECTION, SOLUTION 10 12
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 0409-1312 HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 30 Current NDC, Legacy NDC, 2 package rows 20241206_e9c9ef18-7dfc-4322-b2fc-29b934c30f8b.zip 0409-1312 HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20240517_f9ca2ef5-46d8-475a-a26e-f7c8becd6db7.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 0409-1312-03 00409131203 1 mL in 1 CARTRIDGE 1 ml Historical 0409-1312-16 00409131216 1 mL in 1 SYRINGE 1 ml Historical 0409-1312-30 00409131230 10 CARTRIDGE in 1 CARTON (0409-1312-30) / 1 mL in 1 CARTRIDGE (0409-1312-03) 10 cartridge 2011-12-01 0000-00-00 No No Current 0409-1312-36 00409131236 10 SYRINGE in 1 CELLO PACK (0409-1312-36) / 1 mL in 1 SYRINGE (0409-1312-16) 10 syringe 2021-02-01 0000-00-00 No No Current