ACETAMINOPHEN AND CODEINE

Product NDC
53489-161
11-digit product format
534890161
Labeler code
53489
Product ID
53489-161_57ee1a9a-25d6-41ea-b86c-b9cc5a8cebe6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Mutual Pharmaceutical Company, Inc.
Application
ANDA089673
Marketing category
ANDA
Marketing start
1988-02-10
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53489-161IInactivated by FDA2026-08-10
excluded packagepackage53489-16153489-161-01IInactivated by FDA2026-08-10
excluded packagepackage53489-16153489-161-02IInactivated by FDA2026-08-10
excluded packagepackage53489-16153489-161-05IInactivated by FDA2026-08-10
excluded packagepackage53489-16153489-161-10IInactivated by FDA2026-08-10

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 2 · 110 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 packagepackage53489-161-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-161-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-161-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53489-161-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-161-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-161-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-161-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53489-161-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-161-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-161-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-161-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53489-161-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-161-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-161-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-161-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53489-161-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-161-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-161-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-161-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53489-161-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-161-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-161-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-161-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53489-161-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-161-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-161-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-161-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53489-161-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-161-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-161-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-161-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53489-161-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53489-161-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53489-161-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53489-161-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53489-161-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53489-161-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53489-161-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53489-161-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53489-161-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53489-161-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53489-161-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53489-161-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53489-161-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53489-161-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53489-161-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53489-161-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53489-161-05557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-10
A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-10
A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-10

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089673-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1988-02-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089673-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1988-02-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089673-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-02-108072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]6
Codeine PhosphateACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]6
AcetaminophenACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]6
Codeine AnhydrousACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]6
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]6
magnesium stearateINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]6
Povidone K90INACTIVE INGREDIENTRDH86HJV5ZACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]6
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]6
starch, cornINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]6
stearic acidINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]6