Home NDC 60951-653 morphine sulfate
Product NDC 60951-653
11-digit product format 609510653
Labeler code 60951
Product ID 60951-653_64d03acf-7e17-4be0-b5c0-05dea1125e75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name morphine sulfate
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Par Pharmaceutical
Application ANDA075295
Marketing category ANDA
Marketing start 1998-10-31
Marketing end 2019-10-31
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 60951-653-70 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 60951-653-70 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 60951-653-70 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 60951-653-70 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 60951-653-70 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 60951-653-70 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 60951-653-70 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 60951-653-70 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 60951-653-70 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 60951-653-70 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 60951-653-70 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 60951-653-70 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A075295-001 MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE / ORAL 1998-10-28 A075295-002 MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE / ORAL 1998-10-28 A075295-003 MORPHINE SULFATE MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE / ORAL 1998-10-28 A075295-004 MORPHINE SULFATE MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE / ORAL 2000-09-15 A075295-005 MORPHINE SULFATE MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE / ORAL 2000-09-15
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 6 of 6 · 215 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 2022-09-29 23:25 UTC 2022-09 A075295-001 MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE / ORAL AB 1998-10-28 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075295-002 MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 1998-10-28 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075295-003 MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 1998-10-28 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075295-004 MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2000-09-15 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075295-005 MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2000-09-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075295-001 MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE / ORAL AB 1998-10-28 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075295-002 MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 1998-10-28 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075295-003 MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 1998-10-28 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075295-004 MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2000-09-15 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075295-005 MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2000-09-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075295-001 MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE / ORAL 1998-10-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075295-002 MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE / ORAL 1998-10-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075295-003 MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE / ORAL 1998-10-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075295-004 MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE / ORAL 2000-09-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075295-005 MORPHINE SULFATE 200MG TABLET, EXTENDED RELEASE / ORAL 2000-09-15 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 195 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] 2 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MORPHINE SULFATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MORPHINE SULFATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSE 2208 (15000 MPA.S) INACTIVE INGREDIENT Z78RG6M2N2 MORPHINE SULFATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MORPHINE SULFATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MORPHINE SULFATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MORPHINE SULFATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MORPHINE SULFATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed RxNorm Mappings#