Acetaminophen and Codeine Phosphate

Product NDC
50090-0215
11-digit product format
500900215
Labeler code
50090
Product ID
50090-0215_40e0fef0-f52f-4fd2-84b3-a812cffe483e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN and CODEINE PHOSPHATE
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA087508
Marketing category
ANDA
Marketing start
1981-08-21
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
120 mg/5mL; mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0215DDiscontinued by firm2026-08-03
excluded packagepackage50090-021550090-0215-0DDiscontinued 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 · 11 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 packagepackage50090-0215-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0215-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-0215-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-0215-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-0215-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-0215-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-0215-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-0215-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-0215-00efc9e666f02…f202fb6c5f17…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRS, Approved before 1982

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087508-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAARS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087508-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087508-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087508-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087508-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087508-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087508-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087508-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087508-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087508-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087508-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087508-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087508-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087508-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087508-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087508-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087508-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087508-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A087508-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087508-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087508-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087508-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A087508-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087508-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087508-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087508-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087508-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087508-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087508-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087508-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087508-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087508-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087508-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087508-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087508-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087508-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087508-001AA1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0215-0ML - Milliliter50090-021506dbd93e-7d4c-437e-a0b7-e4792e81465312018-08-13

DailyMed Socrata Ingredients#

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEGenus Lifesciences Inc.95a5d638-3072-4c37-a4cd-f8550328e2c62026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087508
application number: ANDA087508
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEPAI Holdings, LLC dba PAI Pharma95ac6875-6b14-4cde-8efb-80704e39b8d82024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087508
application number: ANDA087508

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0215-050090021500118 mL in 1 BOTTLE (50090-0215-0) 118 ml2014-11-280000-00-00NoNoCurrent