Home NDC 0641-6125 Morphine Sulfate
Product NDC 0641-6125
11-digit product format 006416125
Labeler code 0641
Product ID 0641-6125_fa18221d-2353-4cf6-a210-fb33ee79d3d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA205758
Marketing category ANDA
Marketing start 2015-06-03
Substance MORPHINE SULFATE
Active strength 4 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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205758-001 MORPHINE SULFATE MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 A205758-002 MORPHINE SULFATE MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 A205758-003 MORPHINE SULFATE MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21
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 4 · 126 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 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205758-002 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205758-003 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2015-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205758-001 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RS 2015-05-21 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 122 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Morphine Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MORPHINE SULFATE 4 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1731993 Internal RxNorm lookup 1732006 Internal RxNorm lookup 1732011 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 0641-6125-01 Morphine Sulfate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 10 0641-6125-25 Morphine Sulfate 25 in 1 PACKAGE INJECTION 25 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6125 MORPHINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 10 Current NDC, Legacy NDC, 2 package rows 20240608_6023606c-150c-40c5-9175-598efe2a56c3.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 0641-6125-01 00641612501 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 0641-6125-25 00641612525 25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-6125-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6125-01) 2015-06-03 0000-00-00 No No Current