Home Applications 019034 Application 019034
Type NDA
Sponsor FRESENIUS KABI USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DILAUDID-HP HYDROMORPHONE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Yes No 002 DILAUDID-HP HYDROMORPHONE HYDROCHLORIDE INJECTABLE;INJECTION 250MG/VIAL No No 003 DILAUDID HYDROMORPHONE HYDROCHLORIDE INJECTABLE;INJECTION 1MG/ML Yes Yes 004 DILAUDID HYDROMORPHONE HYDROCHLORIDE INJECTABLE;INJECTION 2MG/ML Yes Yes 005 DILAUDID HYDROMORPHONE HYDROCHLORIDE INJECTABLE;INJECTION 4MG/ML Yes No 006 DILAUDID HYDROMORPHONE HYDROCHLORIDE INJECTABLE;INJECTION 0.2MG/ML Yes Yes 007 DILAUDID HYDROMORPHONE HYDROCHLORIDE INJECTABLE;INJECTION 0.5MG/0.5ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 266 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 N019034-001 DILAUDID-HP 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-002 DILAUDID-HP 250MG/VIAL INJECTABLE / INJECTION 1994-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-003 DILAUDID 1MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-004 DILAUDID 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-005 DILAUDID 4MG/ML INJECTABLE / INJECTION AP RLD, RS 2009-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-006 DILAUDID 0.2MG/ML INJECTABLE / INJECTION AP RLD, RS 2020-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-007 DILAUDID 0.5MG/0.5ML INJECTABLE / INJECTION AP RLD, RS 2017-02-10 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 130 observed states.
Observed Orange Book patent history# Patent history page 1 of 14 · 532 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N019034-001 9731082 2032-04-23 Drug product 2018-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-001 9248229 2034-03-12 Drug product 2018-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-002 9731082 2032-04-23 Drug product 2018-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-002 9248229 2034-03-12 Drug product 2018-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-003 9731082 2032-04-23 Drug product 2018-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-003 9248229 2034-03-12 Drug product 2018-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-004 9731082 2032-04-23 Drug product 2018-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-004 9248229 2034-03-12 Drug product 2018-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-005 9731082 2032-04-23 Drug product 2018-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-005 9248229 2034-03-12 Drug product 2018-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-006 9731082 2032-04-23 Drug product 2023-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-006 9248229 2034-03-12 Drug product 2023-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-007 9731082 2032-04-23 Drug product 2018-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019034-007 9248229 2034-03-12 Drug product 2018-02-05 caaa826d4ba7…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…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 26 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59011-442 DILAUDID HYDROMORPHONE HYDROCHLORIDE Purdue Pharma LP NDA Current 59011-444 DILAUDID HYDROMORPHONE HYDROCHLORIDE Purdue Pharma LP NDA Current 63323-851 Hydromorphone Hydrochloride Hydromorphone Hydrochloride Fresenius Kabi USA, LLC NDA Current 63323-851 Hydromorphone Hydrochloride Hydromorphone Hydrochloride Fresenius Kabi USA, LLC NDA Current 63323-851 Hydromorphone Hydrochloride Hydromorphone Hydrochloride Fresenius Kabi USA, LLC NDA Current 63323-852 Hydromorphone Hydrochloride Hydromorphone Hydrochloride Fresenius Kabi USA, LLC NDA Current 63323-852 Hydromorphone Hydrochloride Hydromorphone Hydrochloride Fresenius Kabi USA, LLC NDA Current 63323-852 Hydromorphone Hydrochloride Hydromorphone Hydrochloride Fresenius Kabi USA, LLC NDA Current 63323-853 Hydromorphone Hydrochloride Hydromorphone Hydrochloride Fresenius Kabi USA, LLC NDA Current 63323-853 Hydromorphone Hydrochloride Hydromorphone Hydrochloride Fresenius Kabi USA, LLC NDA Current 63323-853 Hydromorphone Hydrochloride Hydromorphone Hydrochloride Fresenius Kabi USA, LLC NDA Current 63323-854 Hydromorphone Hydrochloride Hydromorphone Hydrochloride Fresenius Kabi USA, LLC NDA Current 63323-854 Hydromorphone Hydrochloride Hydromorphone Hydrochloride Fresenius Kabi USA, LLC NDA Current 63323-854 Hydromorphone Hydrochloride Hydromorphone Hydrochloride Fresenius Kabi USA, LLC NDA Current 76045-009 Dilaudid Hydromorphone hydrochloride Fresenius Kabi USA, LLC NDA Current 76045-009 Dilaudid Hydromorphone hydrochloride Fresenius Kabi USA, LLC NDA Current 76045-009 Dilaudid Hydromorphone hydrochloride Fresenius Kabi USA, LLC NDA Current 76045-009 Dilaudid Hydromorphone hydrochloride Fresenius Kabi USA, LLC NDA Current 76045-009 Dilaudid Hydromorphone hydrochloride Fresenius Kabi USA, LLC NDA Current 76045-010 Dilaudid Hydromorphone hydrochloride Fresenius Kabi USA, LLC NDA Current 76045-010 Dilaudid Hydromorphone hydrochloride Fresenius Kabi USA, LLC NDA Current 76045-010 Dilaudid Hydromorphone hydrochloride Fresenius Kabi USA, LLC NDA Current 76045-010 Dilaudid Hydromorphone hydrochloride Fresenius Kabi USA, LLC NDA Current 76045-010 Dilaudid Hydromorphone hydrochloride Fresenius Kabi USA, LLC NDA Current 76045-121 Dilaudid Hydromorphone hydrochloride Fresenius Kabi USA, LLC NDA Current 76045-121 Dilaudid Hydromorphone hydrochloride Fresenius Kabi USA, LLC NDA Current