Home NDC 0641-6020 Duramorph
Product NDC 0641-6020
11-digit product format 006416020
Labeler code 0641
Product ID 0641-6020_aa74af85-7068-4254-9a79-c7f3792044a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name morphine sulfate
Dosage form INJECTION
Route EPIDURAL; INTRATHECAL; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA018565
Marketing category NDA
Marketing start 1984-09-18
Substance MORPHINE SULFATE
Active strength .5 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 168 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 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018565-001 DURAMORPH PF 0.5MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018565-002 DURAMORPH PF 1MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018565-003 INFUMORPH 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018565-004 INFUMORPH 25MG/ML INJECTABLE / INJECTION AP RLD, RS 1991-07-19 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Duramorph
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MORPHINE SULFATE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X3P646A2J0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 892473 Internal RxNorm lookup 892489 Internal RxNorm lookup 1728783 Internal RxNorm lookup 1728800 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 0641-6020-01 Duramorph 10 mL in 1 AMPULE INJECTION 10 11 0641-6020-10 Duramorph 10 in 1 CARTON INJECTION 10 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6020 DURAMORPH (MORPHINE SULFATE) INJECTION [HIKMA PHARMACEUTICALS USA INC.] 10 Current NDC, Legacy NDC, 2 package rows 20240410_ebb18761-e5c4-4238-bb84-f9549f500210.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 0641-6020-01 00641602001 10 mL in 1 AMPULE 10 ml Historical 0641-6020-10 00641602010 10 AMPULE in 1 CARTON (0641-6020-10) / 10 mL in 1 AMPULE (0641-6020-01) 10 ampule 1984-09-18 0000-00-00 No No Current