Home NDC 71335-9662 MORPHINE SULFATE
Product NDC 71335-9662
11-digit product format 713359662
Labeler code 71335
Product ID 71335-9662_b1e7450b-172b-49ae-8d13-b5a68dbd7656
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MORPHINE SULFATE
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA212451
Marketing category ANDA
Marketing start 2021-02-11
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 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 A212451-001 MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 A212451-002 MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03
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 2 · 76 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 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212451-001 MORPHINE SULFATE 15MG TABLET / ORAL AB 2020-12-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212451-002 MORPHINE SULFATE 30MG TABLET / ORAL AB 2020-12-03 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A212451-001 CGT 2021-08-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212451-002 CGT 2021-08-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212451-001 CGT 2021-08-10 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212451-002 CGT 2021-08-10 87673890dc5c…
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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 892672 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-9662 MORPHINE SULFATE TABLET [BRYANT RANCH PREPACK] 100 Current NDC, 7 package rows 20230401_d1b0b4ac-69d9-44bf-b7a3-229bd89b9fd6.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 St. Mary's Medical Park Pharmacy 57ee014e-744e-65e1-e063-6394a90a8c93 2026-07-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212451 application number: ANDA212451 MORPHINE SULFATE MORPHINE SULFATE Bryant Ranch Prepack d1b0b4ac-69d9-44bf-b7a3-229bd89b9fd6 2026-04-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212451 application number: ANDA212451 ndc (product): 71335-9662 Morphine Sulfate MORPHINE SULFATE American Health Packaging d66d0cfb-9bfe-490c-90ee-49481c567e85 2025-12-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212451 application number: ANDA212451 MORPHINE SULFATE MORPHINE SULFATE Ascend Laboratories, LLC 07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a 2025-10-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212451 application number: ANDA212451 MORPHINE SULFATE MORPHINE SULFATE Bryant Ranch Prepack 905cd842-2c86-4318-a6c4-92f49de145b3 2025-06-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212451 application number: ANDA212451
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-9662-1 71335966201 60 TABLET in 1 BOTTLE (71335-9662-1) 60 tablet 2026-04-13 No No Current 71335-9662-2 71335966202 30 TABLET in 1 BOTTLE (71335-9662-2) 30 tablet 2026-04-13 No No Current 71335-9662-3 71335966203 90 TABLET in 1 BOTTLE (71335-9662-3) 90 tablet 2023-03-02 No No Current 71335-9662-4 71335966204 120 TABLET in 1 BOTTLE (71335-9662-4) 120 tablet 2026-04-13 No No Current 71335-9662-5 71335966205 15 TABLET in 1 BOTTLE (71335-9662-5) 15 tablet 2026-04-13 No No Current 71335-9662-6 71335966206 180 TABLET in 1 BOTTLE (71335-9662-6) 180 tablet 2026-04-13 No No Current 71335-9662-7 71335966207 20 TABLET in 1 BOTTLE (71335-9662-7) 20 tablet 2026-04-13 No No Current