ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
50090-3011
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

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 Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, GSL05Y1MN6
Rxcui993890

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3011-02023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-02023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-02023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-12023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-12023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-12023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-22023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-22023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-22023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-32023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-32023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-32023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-42023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-42023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-42023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-52023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-52023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-52023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-62023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-62023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-62023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-72023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-72023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-72023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-82023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-82023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-82023-02-07C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-02023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-02023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-02023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-12023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-12023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-12023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-22023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-22023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-22023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-32023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-32023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-32023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-42023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-42023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-42023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-52023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-52023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-52023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-62023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-62023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-62023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-72023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-72023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-72023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-82023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-82023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-3011-82023-01-30C16284748780-1f386c649-e60d-0266-e053-dadaa90a7c1aAcetaminophen 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

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
50090-3011-05009030110020 TABLET in 1 BOTTLE (50090-3011-0) 20 tablet2019-10-090000-00-00NoNoCurrent
50090-3011-15009030110130 TABLET in 1 BOTTLE (50090-3011-1) 30 tablet2017-05-110000-00-00NoNoCurrent
50090-3011-25009030110290 TABLET in 1 BOTTLE (50090-3011-2) 90 tablet2019-10-090000-00-00NoNoCurrent
50090-3011-350090301103100 TABLET in 1 BOTTLE (50090-3011-3) 100 tablet2019-10-090000-00-00NoNoCurrent
50090-3011-45009030110450 TABLET in 1 BOTTLE (50090-3011-4) 50 tablet2019-10-090000-00-00NoNoCurrent
50090-3011-55009030110540 TABLET in 1 BOTTLE (50090-3011-5) 40 tablet2019-10-090000-00-00NoNoCurrent
50090-3011-65009030110615 TABLET in 1 BOTTLE (50090-3011-6) 15 tablet2019-10-090000-00-00NoNoCurrent
50090-3011-75009030110712 TABLET in 1 BOTTLE (50090-3011-7) 12 tablet2019-10-090000-00-00NoNoCurrent
50090-3011-85009030110860 TABLET in 1 BOTTLE (50090-3011-8) 60 tablet2019-10-090000-00-00NoNoCurrent