Home NDC 52544-011 Kadian
Product NDC 52544-011
11-digit product format 525440011
Labeler code 52544
Product ID 52544-011_15770ad4-855d-46cc-ba48-11556f40a7b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name morphine sulfate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA020616
Marketing category NDA
Marketing start 2009-04-07
Marketing end 2020-06-30
Substance MORPHINE SULFATE
Active strength 10 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 52544-011-60 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 52544-011-60 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 52544-011-60 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 52544-011-60 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 52544-011-60 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 52544-011-60 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 52544-011-60 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 52544-011-60 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 52544-011-60 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 52544-011-60 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 52544-011-60 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 52544-011-60 557ba5c1ecfa…9c80585c8c6e…
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 KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 MORPHINE ACTIVE MOIETY 76I7G6D29C KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 DIETHYL PHTHALATE INACTIVE INGREDIENT UF064M00AF KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) INACTIVE INGREDIENT 74G4R6TH13 KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 2