Home NDC 55700-349 Morphine Sulfate
Product NDC 55700-349
11-digit product format 557000349
Labeler code 55700
Product ID 55700-349_8045940a-78db-47ac-897f-72ce63ad7cd3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Quality Care Products LLC
Application ANDA202104
Marketing category ANDA
Marketing start 2013-06-30
Marketing end 0000-00-00
Substance MORPHINE SULFATE
Active strength 20 mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2023-12-31
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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202104-001 MORPHINE SULFATE MORPHINE SULFATE 10MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 A202104-002 MORPHINE SULFATE MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 A202104-003 MORPHINE SULFATE MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 A202104-004 MORPHINE SULFATE MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 A202104-005 MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 A202104-006 MORPHINE SULFATE MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 A202104-007 MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE / ORAL RS 2013-06-03
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 8 · 301 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 A202104-001 MORPHINE SULFATE 10MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202104-002 MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202104-003 MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202104-004 MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202104-005 MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202104-006 MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202104-007 MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE / ORAL RS 2013-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202104-001 MORPHINE SULFATE 10MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202104-002 MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202104-003 MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202104-004 MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202104-005 MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202104-006 MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202104-007 MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE / ORAL RS 2013-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202104-001 MORPHINE SULFATE 10MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202104-002 MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202104-003 MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202104-004 MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202104-005 MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202104-006 MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202104-007 MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE / ORAL RS 2013-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202104-001 MORPHINE SULFATE 10MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202104-002 MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202104-003 MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202104-004 MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202104-005 MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202104-006 MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202104-007 MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE / ORAL RS 2013-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202104-001 MORPHINE SULFATE 10MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202104-002 MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202104-003 MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202104-004 MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202104-005 MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202104-006 MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202104-007 MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE / ORAL RS 2013-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202104-001 MORPHINE SULFATE 10MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202104-002 MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202104-003 MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202104-004 MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202104-005 MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE / ORAL 2013-06-03 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 92 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55700-349-30 55700034930 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55700-349-30) 2018-02-09 0000-00-00 No No Current 55700-349-60 55700034960 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55700-349-60) 2015-12-23 0000-00-00 No No Current