FDA.reportPublic FDA data

Acetaminophen And Codeine

Product NDC
33261-001
11-digit product format
332610001
Labeler code
33261
Product ID
33261-001_52b8a439-688c-43db-bfea-a773b81a2157
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA089805
Marketing category
ANDA
Marketing start
1988-09-30
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; ACETAMINOPHEN
Active strength
30 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
33261-001-022020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-001-102020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-001-122020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-001-142020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-001-152020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-001-202020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-001-252020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-001-282020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-001-302020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-001-402020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-001-502020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-001-602020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-001-902020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-001-02Acetaminophen And Codeine120 in 1 BOTTLE, PLASTICTABLET1203
33261-001-10Acetaminophen And Codeine10 in 1 BOTTLE, PLASTICTABLET103
33261-001-12Acetaminophen And Codeine12 in 1 BOTTLE, PLASTICTABLET123
33261-001-14Acetaminophen And Codeine14 in 1 BOTTLE, PLASTICTABLET143
33261-001-15Acetaminophen And Codeine15 in 1 BOTTLE, PLASTICTABLET153
33261-001-20Acetaminophen And Codeine20 in 1 BOTTLE, PLASTICTABLET203
33261-001-25Acetaminophen And Codeine25 in 1 BOTTLE, PLASTICTABLET253
33261-001-28Acetaminophen And Codeine28 in 1 BOTTLE, PLASTICTABLET283
33261-001-30Acetaminophen And Codeine30 in 1 BOTTLE, PLASTICTABLET303
33261-001-40Acetaminophen And Codeine40 in 1 BOTTLE, PLASTICTABLET403
33261-001-50Acetaminophen And Codeine50 in 1 BOTTLE, PLASTICTABLET503
33261-001-60Acetaminophen And Codeine60 in 1 BOTTLE, PLASTICTABLET603
33261-001-90Acetaminophen And Codeine90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-001-02EA - Each33261-001c278b356-541f-46ac-9846-683330d6bfe212015-10-02
33261-001-12EA - Each33261-00114eb21b9-f85a-4012-931d-9c5a8e4e9a2112015-10-02
33261-001-14EA - Each33261-001c39412c8-e3f7-432b-b960-b13902700eb112015-10-02
33261-001-20EA - Each33261-001529efd83-813d-4e63-98d5-2eda9d138deb12015-10-02
33261-001-25EA - Each33261-00137076501-d57e-4fdf-afd0-11de5278b92b12015-10-02
33261-001-28EA - Each33261-0019cf30a4c-bdef-4827-8b3e-7939e5ac954f12015-10-02
33261-001-30EA - Each33261-0013c9806af-fa58-4d08-8eaa-80319340370412015-10-02
33261-001-40EA - Each33261-0017c0fbada-5b5c-4d6d-8e95-47d2c2fd56c712015-10-02
33261-001-50EA - Each33261-0018d6fed6e-55b4-4f8f-a5ad-85f42b66134c12015-10-02
33261-001-60EA - Each33261-00122ce1d3b-c1d8-49bf-b3cc-ce00f708fdb812015-10-02
33261-001-90EA - Each33261-0018515657a-b763-4ec7-8b13-bc24889778cd12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [AIDAREX PHARMACEUTICALS LLC]3
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [AIDAREX PHARMACEUTICALS LLC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [AIDAREX PHARMACEUTICALS LLC]3
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [AIDAREX PHARMACEUTICALS LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [AIDAREX PHARMACEUTICALS LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [AIDAREX PHARMACEUTICALS LLC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [AIDAREX PHARMACEUTICALS LLC]3
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [AIDAREX PHARMACEUTICALS LLC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [AIDAREX PHARMACEUTICALS LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [AIDAREX PHARMACEUTICALS LLC]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [AIDAREX PHARMACEUTICALS LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-001ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 13 package rows20120914_6d223ecc-a4ef-452b-9bc3-51162f6a28d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN6d223ecc-a4ef-452b-9bc3-51162f6a28d23
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSN6d223ecc-a4ef-452b-9bc3-51162f6a28d23
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD6d223ecc-a4ef-452b-9bc3-51162f6a28d23
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCD6d223ecc-a4ef-452b-9bc3-51162f6a28d23
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY6d223ecc-a4ef-452b-9bc3-51162f6a28d23
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSY6d223ecc-a4ef-452b-9bc3-51162f6a28d23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-001-0233261000102120 in 1 BOTTLE, PLASTICHistorical
33261-001-103326100011010 in 1 BOTTLE, PLASTICHistorical
33261-001-123326100011212 in 1 BOTTLE, PLASTICHistorical
33261-001-143326100011414 in 1 BOTTLE, PLASTICHistorical
33261-001-153326100011515 in 1 BOTTLE, PLASTICHistorical
33261-001-203326100012020 in 1 BOTTLE, PLASTICHistorical
33261-001-253326100012525 in 1 BOTTLE, PLASTICHistorical
33261-001-283326100012828 in 1 BOTTLE, PLASTICHistorical
33261-001-303326100013030 in 1 BOTTLE, PLASTICHistorical
33261-001-403326100014040 in 1 BOTTLE, PLASTICHistorical
33261-001-503326100015050 in 1 BOTTLE, PLASTICHistorical
33261-001-603326100016060 in 1 BOTTLE, PLASTICHistorical
33261-001-903326100019090 in 1 BOTTLE, PLASTICHistorical