Home NDC 63323-853 Hydromorphone Hydrochloride
Product NDC 63323-853
11-digit product format 633230853
Labeler code 63323
Product ID 63323-853_9e8522c6-595c-46f9-bb25-272aa4683e0f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydromorphone Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application NDA019034
Marketing category NDA
Marketing start 2017-12-15
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 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019034-001 DILAUDID-HP HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-01-11 N019034-002 DILAUDID-HP HYDROMORPHONE HYDROCHLORIDE 250MG/VIAL INJECTABLE / INJECTION 1994-08-04 N019034-003 DILAUDID HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 N019034-004 DILAUDID HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 N019034-005 DILAUDID HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 N019034-006 DILAUDID HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP RLD, RS 2020-01-16 N019034-007 DILAUDID HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE / INJECTION AP RLD, RS 2017-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N019034-001 9731082 2032-04-23 Drug product 2018-02-05 N019034-001 9248229 2034-03-12 Drug product 2018-02-05 N019034-002 9731082 2032-04-23 Drug product 2018-02-05 N019034-002 9248229 2034-03-12 Drug product 2018-02-05 N019034-003 9731082 2032-04-23 Drug product 2018-02-05 N019034-003 9248229 2034-03-12 Drug product 2018-02-05 N019034-004 9731082 2032-04-23 Drug product 2018-02-05 N019034-004 9248229 2034-03-12 Drug product 2018-02-05 N019034-005 9731082 2032-04-23 Drug product 2018-02-05 N019034-005 9248229 2034-03-12 Drug product 2018-02-05 N019034-006 9731082 2032-04-23 Drug product 2023-05-23 N019034-006 9248229 2034-03-12 Drug product 2023-05-23 N019034-007 9731082 2032-04-23 Drug product 2018-02-05 N019034-007 9248229 2034-03-12 Drug product 2018-02-05
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 7 · 259 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 N019034-001 DILAUDID-HP 10MG/ML INJECTABLE / INJECTION RLD 1984-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-002 DILAUDID-HP 250MG/VIAL INJECTABLE / INJECTION 1994-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-003 DILAUDID 1MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-004 DILAUDID 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-005 DILAUDID 4MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-006 DILAUDID 0.2MG/ML INJECTABLE / INJECTION AP RLD, RS 2020-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-007 DILAUDID 0.5MG/0.5ML INJECTABLE / INJECTION AP RLD, RS 2017-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-001 DILAUDID-HP 10MG/ML INJECTABLE / INJECTION RLD 1984-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-002 DILAUDID-HP 250MG/VIAL INJECTABLE / INJECTION 1994-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-003 DILAUDID 1MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-004 DILAUDID 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-005 DILAUDID 4MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-006 DILAUDID 0.2MG/ML INJECTABLE / INJECTION AP RLD, RS 2020-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-007 DILAUDID 0.5MG/0.5ML INJECTABLE / INJECTION AP RLD, RS 2017-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019034-001 DILAUDID-HP 10MG/ML INJECTABLE / INJECTION RLD 1984-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-002 DILAUDID-HP 250MG/VIAL INJECTABLE / INJECTION 1994-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-003 DILAUDID 1MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-004 DILAUDID 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-005 DILAUDID 4MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-006 DILAUDID 0.2MG/ML INJECTABLE / INJECTION AP RLD, RS 2020-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-007 DILAUDID 0.5MG/0.5ML INJECTABLE / INJECTION AP RLD, RS 2017-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019034-001 DILAUDID-HP 10MG/ML INJECTABLE / INJECTION RLD 1984-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019034-002 DILAUDID-HP 250MG/VIAL INJECTABLE / INJECTION 1994-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019034-003 DILAUDID 1MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019034-004 DILAUDID 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019034-005 DILAUDID 4MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019034-006 DILAUDID 0.2MG/ML INJECTABLE / INJECTION AP RLD, RS 2020-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019034-007 DILAUDID 0.5MG/0.5ML INJECTABLE / INJECTION AP RLD, RS 2017-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019034-001 DILAUDID-HP 10MG/ML INJECTABLE / INJECTION RLD 1984-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019034-002 DILAUDID-HP 250MG/VIAL INJECTABLE / INJECTION 1994-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019034-003 DILAUDID 1MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019034-004 DILAUDID 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019034-005 DILAUDID 4MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019034-006 DILAUDID 0.2MG/ML INJECTABLE / INJECTION AP RLD, RS 2020-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019034-007 DILAUDID 0.5MG/0.5ML INJECTABLE / INJECTION AP RLD, RS 2017-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019034-001 DILAUDID-HP 10MG/ML INJECTABLE / INJECTION RLD 1984-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019034-002 DILAUDID-HP 250MG/VIAL INJECTABLE / INJECTION 1994-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019034-003 DILAUDID 1MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019034-004 DILAUDID 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019034-005 DILAUDID 4MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 124 observed states.
Observed Orange Book patent history# Patent history page 1 of 13 · 518 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N019034-001 9731082 2032-04-23 Drug product 2018-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-001 9248229 2034-03-12 Drug product 2018-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-002 9731082 2032-04-23 Drug product 2018-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-002 9248229 2034-03-12 Drug product 2018-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-003 9731082 2032-04-23 Drug product 2018-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-003 9248229 2034-03-12 Drug product 2018-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-004 9731082 2032-04-23 Drug product 2018-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-004 9248229 2034-03-12 Drug product 2018-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-005 9731082 2032-04-23 Drug product 2018-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-005 9248229 2034-03-12 Drug product 2018-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-006 9731082 2032-04-23 Drug product 2023-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-006 9248229 2034-03-12 Drug product 2023-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-007 9731082 2032-04-23 Drug product 2018-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019034-007 9248229 2034-03-12 Drug product 2018-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-001 9731082 2032-04-23 Drug product 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-001 9248229 2034-03-12 Drug product 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-002 9731082 2032-04-23 Drug product 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-002 9248229 2034-03-12 Drug product 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-003 9731082 2032-04-23 Drug product 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-003 9248229 2034-03-12 Drug product 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-004 9731082 2032-04-23 Drug product 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-004 9248229 2034-03-12 Drug product 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-005 9731082 2032-04-23 Drug product 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-005 9248229 2034-03-12 Drug product 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-006 9731082 2032-04-23 Drug product 2023-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-006 9248229 2034-03-12 Drug product 2023-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-007 9731082 2032-04-23 Drug product 2018-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019034-007 9248229 2034-03-12 Drug product 2018-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019034-001 9731082 2032-04-23 Drug product 2018-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-001 9248229 2034-03-12 Drug product 2018-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-002 9731082 2032-04-23 Drug product 2018-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-002 9248229 2034-03-12 Drug product 2018-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-003 9731082 2032-04-23 Drug product 2018-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-003 9248229 2034-03-12 Drug product 2018-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-004 9731082 2032-04-23 Drug product 2018-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-004 9248229 2034-03-12 Drug product 2018-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-005 9731082 2032-04-23 Drug product 2018-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-005 9248229 2034-03-12 Drug product 2018-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-006 9731082 2032-04-23 Drug product 2023-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019034-006 9248229 2034-03-12 Drug product 2023-05-23 6a471c1ec25d…
Additional Listing Data#
Finished product Yes
Brand name base Hydromorphone Hydrochloride
Listing expiration 2026-12-31 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 897653 Internal RxNorm lookup 897753 Internal RxNorm lookup 1724276 Internal RxNorm lookup 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 63323-853-03 Hydromorphone Hydrochloride 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 6 63323-853-25 Hydromorphone Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-853 HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20250418_e034eb96-03e0-46e1-8b92-5e1f94555e7b.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 63323-853-03 63323085303 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 63323-853-25 63323085325 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-853-25) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-853-03) 2017-12-15 0000-00-00 No No Current