ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
50090-3011
Requested package NDC
50090-3011-4
11-digit product format
500903011
Labeler code
50090
Product ID
50090-3011_e01a0c2d-89e5-4de2-8ca1-b35dd1b6fc7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040419
Marketing category
ANDA
Marketing start
2001-05-31
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300; 60 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-301150090-3011-4DDiscontinued by firm2026-08-03

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-301150090-3011-4DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-301150090-3011-4DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31
A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31
A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040419-001AA
A040419-002AA
A040419-003AA

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 UTC2026-02A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040419-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040419-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040419-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040419-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040419-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040419-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040419-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040419-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040419-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040419-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040419-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040419-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040419-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040419-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040419-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040419-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040419-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040419-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040419-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040419-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040419-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040419-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040419-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040419-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040419-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040419-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040419-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040419-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040419-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040419-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040419-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040419-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040419-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040419-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040419-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040419-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040419-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040419-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040419-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040419-001AA18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
ACETAMINOPHEN AND CODEINE PHOSPHATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN300 mg/1
CODEINE PHOSPHATE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
GSL05Y1MN6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
993890Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9ca1321e-380a-48d7-8a58-c6501858c1c0Available on FDA.report

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-3011-02023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-02023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-02023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-12023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-12023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-12023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-22023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-22023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-22023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-32023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-32023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-32023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-42023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-42023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-42023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-52023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-52023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-52023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-62023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-62023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-62023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-72023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-72023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-72023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-82023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-82023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-82023-02-07Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-02023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-02023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-02023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-12023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-12023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-12023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-22023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-22023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-22023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-32023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-32023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-32023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-42023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-42023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-42023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-52023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-52023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-52023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-62023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-62023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-62023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-72023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-72023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-72023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-82023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-82023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-82023-01-30Acetaminophen and Codeine Phosphate Tablets USP CIII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3011-0ACETAMINOPHEN AND CODEINE PHOSPHATE20 in 1 BOTTLETABLET2018
50090-3011-1ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BOTTLETABLET3018
50090-3011-2ACETAMINOPHEN AND CODEINE PHOSPHATE90 in 1 BOTTLETABLET9018
50090-3011-3ACETAMINOPHEN AND CODEINE PHOSPHATE100 in 1 BOTTLETABLET10018
50090-3011-4ACETAMINOPHEN AND CODEINE PHOSPHATE50 in 1 BOTTLETABLET5018
50090-3011-5ACETAMINOPHEN AND CODEINE PHOSPHATE40 in 1 BOTTLETABLET4018
50090-3011-6ACETAMINOPHEN AND CODEINE PHOSPHATE15 in 1 BOTTLETABLET1518
50090-3011-7ACETAMINOPHEN AND CODEINE PHOSPHATE12 in 1 BOTTLETABLET1218
50090-3011-8ACETAMINOPHEN AND CODEINE PHOSPHATE60 in 1 BOTTLETABLET6018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3011-1EA - Each50090-3011e01359d6-f3e7-4650-93fd-9716610e712c12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3011ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 9 package rows20250403_9ca1321e-380a-48d7-8a58-c6501858c1c0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATESpecGx LLCeadc80fa-13c3-471a-a22f-6fe7e1ab290f2026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEUnit Dose Solutions, Inc.537245e8-5e2a-c3e0-e063-6394a90ac8582026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATESt. Mary's Medical Park Pharmacyeac5f350-93e5-4dc2-e053-2a95a90aed602026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.5c96d033-bf7c-47de-aa0d-5998b3bf4a632026-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutions9ca1321e-380a-48d7-8a58-c6501858c1c02026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ndc (package): 50090-3011-4
ndc (product): 50090-3011
ndc11 (package): 50090301104
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutionsdff53120-a609-4720-bd69-2391798c7dee2026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutions297dc9ff-e34f-434b-b1a4-4c995a5bac8b2026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.55d494b1-c828-4841-8f64-75b92cd54cb62026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.2453d635-989d-4569-96b3-4efaf61cca712026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepacka6e9b316-549d-4058-8c08-407e4ce5c2552025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_Rx8d7ca633-4448-3507-e053-2a95a90a12872025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_Rx8d7d6fa4-cc9f-6b4b-e053-2995a90a72862025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.73e2086e-f513-537f-e053-2991aa0a13482025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEDirect_Rxe78e50c0-36da-528e-e053-2995a90a3d802025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEAphena Pharma Solutions - Tennessee, LLCd53bf9b7-1652-4287-a0c1-e89f6f0cb7f12025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEQuality Care Products, LLC3b455938-7bbc-4626-939b-40b37709befb2024-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack3f7737d1-ec78-467e-8903-9cb8eba0ab0b2024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack18315a6f-9e89-46d7-81d3-905b8a51aa792024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LPa8f8bb34-6d61-47a8-b58b-0b67634580522024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.6f2ce909-6356-1c2c-e053-2a91aa0a01352024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSN9ca1321e-380a-48d7-8a58-c6501858c1c018
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCD9ca1321e-380a-48d7-8a58-c6501858c1c018
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSY9ca1321e-380a-48d7-8a58-c6501858c1c018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3011-45009030110450 TABLET in 1 BOTTLE (50090-3011-4) 50 tablet2019-10-090000-00-00NoNoCurrent