Home NDC 72162-1282 Morphine Sulfate
Product NDC 72162-1282
11-digit product format 721621282
Labeler code 72162
Product ID 72162-1282_30a2fbf8-63f9-4da6-aef0-18b16b631429
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form SOLUTION
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA203518
Marketing category ANDA
Marketing start 2015-09-21
Substance MORPHINE SULFATE
Active strength 20 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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203518-001 MORPHINE SULFATE MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2015-05-12 A203518-002 MORPHINE SULFATE MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203518-002 AA
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 · 86 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 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2015-05-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL 2015-05-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203518-001 MORPHINE SULFATE 10MG/5ML SOLUTION / ORAL AA 2015-05-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203518-002 MORPHINE SULFATE 100MG/5ML SOLUTION / ORAL AA 2015-05-12 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 83 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 20 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 892625 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 72162-1282-2 Morphine Sulfate 1 in 1 CARTON SOLUTION 1 102 72162-1282-2 Morphine Sulfate 120 mL in 1 BOTTLE, UNIT-DOSE SOLUTION 120 102 72162-1282-3 Morphine Sulfate 1 in 1 CARTON SOLUTION 1 102 72162-1282-3 Morphine Sulfate 30 mL in 1 BOTTLE, UNIT-DOSE SOLUTION 30 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-1282 MORPHINE SULFATE SOLUTION [BRYANT RANCH PREPACK] 100 Current NDC, 4 package rows 20240208_367d508b-3226-42a9-8dc6-f67cdc9979f3.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Morphine Sulfate MORPHINE SULFATE Bryant Ranch Prepack 367d508b-3226-42a9-8dc6-f67cdc9979f3 2026-05-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203518 application number: ANDA203518 ndc (product): 72162-1282 Morphine Sulfate MORPHINE SULFATE American Health Packaging 5422cdac-8073-41fc-8665-ffe9797f5c02 2026-05-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203518 application number: ANDA203518 Morphine Sulfate MORPHINE SULFATE Cranbury Pharmaceuticals, LLC d8598654-94ad-4cfb-81d2-9b68e013a428 2026-02-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203518 application number: ANDA203518 Morphine Sulfate MORPHINE SULFATE Bryant Ranch Prepack 9bb1fef7-4159-4dca-8a8c-37e53ccc6bab 2024-12-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203518 application number: ANDA203518 Morphine Sulfate MORPHINE SULFATE Bryant Ranch Prepack b7b86b6d-9a39-494c-bf65-f62e4cdc5807 2023-03-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203518 application number: ANDA203518
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72162-1282-2 72162128202 1 BOTTLE, UNIT-DOSE in 1 CARTON (72162-1282-2) / 120 mL in 1 BOTTLE, UNIT-DOSE 2024-02-07 No No Current 72162-1282-3 72162128203 1 BOTTLE, UNIT-DOSE in 1 CARTON (72162-1282-3) / 30 mL in 1 BOTTLE, UNIT-DOSE 2024-02-07 No No Current