Home NDC 65597-302 MorphaBond
Product NDC 65597-302
11-digit product format 655970302
Labeler code 65597
Product ID 65597-302_a26e86c6-febc-4143-802d-5f083e99e196
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name morphine sulfate
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Daiichi Sankyo Inc.
Application NDA206544
Marketing category NDA
Marketing start 2017-03-02
Marketing end 2021-01-22
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206544-001 MORPHABOND ER MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE / ORAL RLD 2015-10-02 N206544-002 MORPHABOND ER MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE / ORAL RLD 2015-10-02 N206544-003 MORPHABOND ER MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE / ORAL RLD 2015-10-02 N206544-004 MORPHABOND ER MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE / ORAL RLD 2015-10-02
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206544-001 10314788 2028-08-12 Drug product 2019-07-10 N206544-001 7955619 2028-08-12 Drug product 2016-03-24 N206544-002 10314788 2028-08-12 Drug product 2019-07-10 N206544-002 7955619 2028-08-12 Drug product 2016-03-24 N206544-003 10314788 2028-08-12 Drug product 2019-07-10 N206544-003 7955619 2028-08-12 Drug product 2016-03-24 N206544-004 10314788 2028-08-12 Drug product 2019-07-10 N206544-004 7955619 2028-08-12 Drug product 2016-03-24
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.
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 2026-08-01 22:54:32 2026-06 N206544-001 MORPHABOND ER 15MG TABLET, EXTENDED RELEASE / ORAL RLD 2015-10-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N206544-002 MORPHABOND ER 30MG TABLET, EXTENDED RELEASE / ORAL RLD 2015-10-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N206544-003 MORPHABOND ER 60MG TABLET, EXTENDED RELEASE / ORAL RLD 2015-10-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N206544-004 MORPHABOND ER 100MG TABLET, EXTENDED RELEASE / ORAL RLD 2015-10-02 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N206544-001 10314788 2028-08-12 Drug product 2019-07-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N206544-001 7955619 2028-08-12 Drug product 2016-03-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N206544-002 10314788 2028-08-12 Drug product 2019-07-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N206544-002 7955619 2028-08-12 Drug product 2016-03-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N206544-003 10314788 2028-08-12 Drug product 2019-07-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N206544-003 7955619 2028-08-12 Drug product 2016-03-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N206544-004 10314788 2028-08-12 Drug product 2019-07-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N206544-004 7955619 2028-08-12 Drug product 2016-03-24 a50c72e98297…