Home NDC 0054-0236 Morphine Sulfate
Product NDC 0054-0236
11-digit product format 000540236
Labeler code 0054
Product ID 0054-0236_c89c4f71-eab3-4b74-b098-fcd31d5aa0dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA022207
Marketing category NDA
Marketing start 2008-03-17
Substance MORPHINE SULFATE
Active strength 30 mg/1
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N022207-001 MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 N022207-002 MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 84 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 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 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 30 mg/1
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 892582 Internal RxNorm lookup 892672 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 0054-0236-24 Morphine Sulfate 100 in 1 CARTON TABLET 100 13 0054-0236-24 Morphine Sulfate 1 in 1 BLISTER PACK TABLET 1 13 0054-0236-25 Morphine Sulfate 100 in 1 BOTTLE TABLET 100 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3372 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3372 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MORPHINE SULFATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3372 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MORPHINE SULFATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3372 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MORPHINE SULFATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3372 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MORPHINE SULFATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3372 MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE TABLET [BRYANT RANCH PREPACK] 1004 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE TABLET [BRYANT RANCH PREPACK] 1004 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MORPHINE SULFATE TABLET [BRYANT RANCH PREPACK] 1004 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MORPHINE SULFATE TABLET [BRYANT RANCH PREPACK] 1004 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MORPHINE SULFATE TABLET [BRYANT RANCH PREPACK] 1004 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MORPHINE SULFATE TABLET [BRYANT RANCH PREPACK] 1004 MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] 7 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MORPHINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] 7 MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC] 4 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MORPHINE SULFATE TABLET [ROXANE LABORATORIES, INC] 4 MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE TABLET [STAT RX USA LLC] 2 MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE TABLET [H.J. HARKINS COMPANY, INC.] 2 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE TABLET [STAT RX USA LLC] 2 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE TABLET [H.J. HARKINS COMPANY, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MORPHINE SULFATE TABLET [STAT RX USA LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MORPHINE SULFATE TABLET [STAT RX USA LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MORPHINE SULFATE TABLET [STAT RX USA LLC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MORPHINE SULFATE TABLET [STAT RX USA LLC] 2 MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] 1 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MORPHINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0236 MORPHINE SULFATE TABLET [HIKMA PHARMACEUTICALS USA INC.] 11 Current NDC, Legacy NDC, 3 package rows 20231219_3c847554-3b4b-4d24-a145-2ef7e9b83699.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 Marketing end Sample Exclude flag Status 0054-0236-24 00054023624 100 BLISTER PACK in 1 CARTON (0054-0236-24) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2008-03-17 0000-00-00 No No Current 0054-0236-25 00054023625 100 TABLET in 1 BOTTLE (0054-0236-25) 100 tablet 2008-03-17 0000-00-00 No No Current