Home DailyMed 21c5f321-ece9-4678-a84c-00d497b06103 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-02-13
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:33:53 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018565-001 DURAMORPH PF MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 N018565-002 DURAMORPH PF MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 N018565-003 INFUMORPH MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 N018565-004 INFUMORPH MORPHINE SULFATE 25MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 · 172 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 N018565-001 DURAMORPH PF 0.5MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018565-002 DURAMORPH PF 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018565-003 INFUMORPH 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018565-004 INFUMORPH 25MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018565-001 DURAMORPH PF 0.5MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018565-002 DURAMORPH PF 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018565-003 INFUMORPH 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018565-004 INFUMORPH 25MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018565-001 DURAMORPH PF 0.5MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018565-002 DURAMORPH PF 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018565-003 INFUMORPH 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018565-004 INFUMORPH 25MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018565-001 DURAMORPH PF 0.5MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018565-002 DURAMORPH PF 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018565-003 INFUMORPH 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018565-004 INFUMORPH 25MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018565-001 DURAMORPH PF 0.5MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018565-002 DURAMORPH PF 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018565-003 INFUMORPH 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018565-004 INFUMORPH 25MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018565-001 DURAMORPH PF 0.5MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018565-002 DURAMORPH PF 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018565-003 INFUMORPH 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018565-004 INFUMORPH 25MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018565-001 DURAMORPH PF 0.5MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018565-002 DURAMORPH PF 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018565-003 INFUMORPH 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018565-004 INFUMORPH 25MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018565-001 DURAMORPH PF 0.5MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018565-002 DURAMORPH PF 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018565-003 INFUMORPH 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018565-004 INFUMORPH 25MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018565-001 DURAMORPH PF 0.5MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018565-002 DURAMORPH PF 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018565-003 INFUMORPH 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018565-004 INFUMORPH 25MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018565-001 DURAMORPH PF 0.5MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018565-002 DURAMORPH PF 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018565-003 INFUMORPH 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018565-004 INFUMORPH 25MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.