FDA.reportPublic FDA data

Kadian

Product NDC
0023-6017
11-digit product format
000236017
Labeler code
0023
Product ID
0023-6017_4e3fa51f-456d-4863-af4b-1e1ae5e59b72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA020616
Marketing category
NDA
Marketing start
2009-04-07
Marketing end
2023-02-28
Substance
MORPHINE SULFATE
Active strength
80 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0023-6017DDiscontinued by firm2026-08-17
excluded packagepackage0023-60170023-6017-60DDiscontinued by firm2026-08-17

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0023-6017-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0023-6017-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0023-6017-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0023-6017-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0023-6017-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0023-6017-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0023-6017-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0023-6017-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0023-6017-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0023-6017-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0023-6017-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0023-6017-60557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020616-001KADIANMORPHINE SULFATE20MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03
N020616-002KADIANMORPHINE SULFATE50MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03
N020616-003KADIANMORPHINE SULFATE100MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03
N020616-004KADIANMORPHINE SULFATE30MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-09
N020616-005KADIANMORPHINE SULFATE60MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-09
N020616-006KADIANMORPHINE SULFATE80MGCAPSULE, EXTENDED RELEASE / ORALRLD2006-10-27
N020616-007KADIANMORPHINE SULFATE200MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-02-27
N020616-008KADIANMORPHINE SULFATE10MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-04-20
N020616-009KADIANMORPHINE SULFATE40MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09
N020616-010KADIANMORPHINE SULFATE70MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09
N020616-011KADIANMORPHINE SULFATE130MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09
N020616-012KADIANMORPHINE SULFATE150MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09

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 · 504 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020616-001KADIAN20MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-002KADIAN50MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-003KADIAN100MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-004KADIAN30MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-005KADIAN60MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-006KADIAN80MGCAPSULE, EXTENDED RELEASE / ORALRLD2006-10-27caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-007KADIAN200MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-008KADIAN10MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-04-20caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-009KADIAN40MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-010KADIAN70MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-011KADIAN130MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020616-012KADIAN150MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020616-001KADIAN20MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-002KADIAN50MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-003KADIAN100MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-004KADIAN30MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-005KADIAN60MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-006KADIAN80MGCAPSULE, EXTENDED RELEASE / ORALRLD2006-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-007KADIAN200MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-008KADIAN10MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-009KADIAN40MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-010KADIAN70MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-011KADIAN130MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020616-012KADIAN150MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-001KADIAN20MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-002KADIAN50MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-003KADIAN100MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-004KADIAN30MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-005KADIAN60MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-006KADIAN80MGCAPSULE, EXTENDED RELEASE / ORALRLD2006-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-007KADIAN200MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-008KADIAN10MGCAPSULE, EXTENDED RELEASE / ORALRLD2007-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-009KADIAN40MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-010KADIAN70MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-011KADIAN130MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020616-012KADIAN150MGCAPSULE, EXTENDED RELEASE / ORALRLD2012-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020616-001KADIAN20MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020616-002KADIAN50MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020616-003KADIAN100MGCAPSULE, EXTENDED RELEASE / ORALRLD1996-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020616-004KADIAN30MGCAPSULE, EXTENDED RELEASE / ORALRLD2001-03-096a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N020616-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-006AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-008AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-009AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020616-010AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-005AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-006AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-008AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020616-009AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020616-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-005AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-006AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-008AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020616-009AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020616-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-004AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-005AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-006AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-008AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020616-009AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020616-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020616-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020616-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020616-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020616-005AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020616-006AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020616-008AB1c0c555d07b60…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-6017-60EA - Each0023-6017b3d1abd0-f66a-4559-9a53-bff27228946d12019-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-6017-600002360176060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0023-6017-60) 2009-04-072023-02-28NoNoCurrent