Home NDC 0641-6192 Morphine Sulfate
Product NDC 0641-6192
11-digit product format 006416192
Labeler code 0641
Product ID 0641-6192_cbc693d6-fa17-4710-b91f-22c4f5d74793
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA211452
Marketing category ANDA
Marketing start 2025-04-18
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211452-001 MORPHINE SULFATE MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP 2023-01-12 A211452-002 MORPHINE SULFATE MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP 2023-01-12 A211452-003 MORPHINE SULFATE MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP 2023-01-12 A211452-004 MORPHINE SULFATE MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2023-01-12 A211452-005 MORPHINE SULFATE MORPHINE SULFATE 15MG/ML INJECTABLE / INJECTION 2023-01-12
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 3 · 120 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 A211452-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP 2023-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211452-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP 2023-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211452-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP 2023-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211452-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2023-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211452-005 MORPHINE SULFATE 15MG/ML INJECTABLE / INJECTION 2023-01-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211452-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP 2023-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211452-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP 2023-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211452-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP 2023-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211452-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2023-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211452-005 MORPHINE SULFATE 15MG/ML INJECTABLE / INJECTION 2023-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211452-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP 2023-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211452-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP 2023-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211452-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP 2023-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211452-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2023-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211452-005 MORPHINE SULFATE 15MG/ML INJECTABLE / INJECTION 2023-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211452-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP 2023-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211452-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP 2023-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211452-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP 2023-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211452-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2023-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211452-005 MORPHINE SULFATE 15MG/ML INJECTABLE / INJECTION 2023-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211452-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP 2023-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211452-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP 2023-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211452-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP 2023-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211452-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2023-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211452-005 MORPHINE SULFATE 15MG/ML INJECTABLE / INJECTION 2023-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211452-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP 2023-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211452-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP 2023-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211452-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP 2023-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211452-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2023-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211452-005 MORPHINE SULFATE 15MG/ML INJECTABLE / INJECTION 2023-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211452-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP 2023-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211452-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP 2023-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211452-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP 2023-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211452-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2023-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211452-005 MORPHINE SULFATE 15MG/ML INJECTABLE / INJECTION 2023-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211452-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP 2023-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211452-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP 2023-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211452-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP 2023-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211452-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP 2023-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211452-005 MORPHINE SULFATE 15MG/ML INJECTABLE / INJECTION 2023-01-12 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 96 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998212 Internal RxNorm lookup 998213 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 0641-6192-10 Morphine Sulfate 10 in 1 PACKAGE INJECTION 10 5 0641-6192-10 Morphine Sulfate 1 mL in 1 SYRINGE INJECTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6192 MORPHINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 5 Current NDC, 2 package rows 20250515_69a0d5be-3211-4b7f-962b-e9d9a507321f.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0641-6192-10 00641619210 10 SYRINGE in 1 PACKAGE (0641-6192-10) / 1 mL in 1 SYRINGE 10 syringe 2025-04-18 No No Current