Home NDC 0228-3502 Morphine sulfate
Product NDC 0228-3502
11-digit product format 002283502
Labeler code 0228
Product ID 0228-3502_30e79184-ceeb-4a0b-931f-7358f556987d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine sulfate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA020616
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2011-11-11
Marketing end 2023-02-28
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 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 · 36 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 · 12 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020616-001 KADIAN MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 N020616-002 KADIAN MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 N020616-003 KADIAN MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 N020616-004 KADIAN MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2001-03-09 N020616-005 KADIAN MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2001-03-09 N020616-006 KADIAN MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-27 N020616-007 KADIAN MORPHINE SULFATE 200MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2007-02-27 N020616-008 KADIAN MORPHINE SULFATE 10MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2007-04-20 N020616-009 KADIAN MORPHINE SULFATE 40MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 N020616-010 KADIAN MORPHINE SULFATE 70MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 N020616-011 KADIAN MORPHINE SULFATE 130MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 N020616-012 KADIAN MORPHINE SULFATE 150MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09
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 13 · 516 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 N020616-001 KADIAN 20MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020616-002 KADIAN 50MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020616-003 KADIAN 100MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020616-004 KADIAN 30MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2001-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020616-005 KADIAN 60MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2001-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020616-006 KADIAN 80MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020616-007 KADIAN 200MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2007-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020616-008 KADIAN 10MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2007-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020616-009 KADIAN 40MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020616-010 KADIAN 70MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020616-011 KADIAN 130MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020616-012 KADIAN 150MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020616-001 KADIAN 20MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020616-002 KADIAN 50MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020616-003 KADIAN 100MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020616-004 KADIAN 30MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2001-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020616-005 KADIAN 60MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2001-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020616-006 KADIAN 80MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020616-007 KADIAN 200MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2007-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020616-008 KADIAN 10MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2007-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020616-009 KADIAN 40MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020616-010 KADIAN 70MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020616-011 KADIAN 130MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020616-012 KADIAN 150MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020616-001 KADIAN 20MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020616-002 KADIAN 50MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020616-003 KADIAN 100MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020616-004 KADIAN 30MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2001-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020616-005 KADIAN 60MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2001-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020616-006 KADIAN 80MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020616-007 KADIAN 200MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2007-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020616-008 KADIAN 10MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2007-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020616-009 KADIAN 40MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020616-010 KADIAN 70MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020616-011 KADIAN 130MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020616-012 KADIAN 150MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2012-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020616-001 KADIAN 20MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020616-002 KADIAN 50MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020616-003 KADIAN 100MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1996-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020616-004 KADIAN 30MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2001-03-09 31067a03dcf5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 DIETHYL PHTHALATE INACTIVE INGREDIENT UF064M00AF MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 SHELLAC INACTIVE INGREDIENT 46N107B71O MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 SUCROSE INACTIVE INGREDIENT C151H8M554 MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0228-3502-06 00228350206 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3502-06) 2011-11-11 0000-00-00 No No Current 0228-3502-11 00228350211 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3502-11) 2011-11-11 0000-00-00 No No Current