FDA.reportPublic FDA data

Acetaminophen And Codeine

Product NDC
33261-002
11-digit product format
332610002
Labeler code
33261
Product ID
33261-002_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
ANDA089828
Marketing category
ANDA
Marketing start
1988-09-30
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; ACETAMINOPHEN
Active strength
60 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
33261-002-022020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-002-102020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-002-122020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-002-142020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-002-152020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-002-202020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-002-252020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-002-282020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-002-302020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-002-402020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-002-502020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-002-602020-01-31C16284748780-19d75b9d0-df2d-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
33261-002-902020-01-31C16284748780-19d75b9d0-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
33261-002-02Acetaminophen And Codeine120 in 1 BOTTLE, PLASTICTABLET1203
33261-002-10Acetaminophen And Codeine10 in 1 BOTTLE, PLASTICTABLET103
33261-002-12Acetaminophen And Codeine12 in 1 BOTTLE, PLASTICTABLET123
33261-002-14Acetaminophen And Codeine14 in 1 BOTTLE, PLASTICTABLET143
33261-002-15Acetaminophen And Codeine15 in 1 BOTTLE, PLASTICTABLET153
33261-002-20Acetaminophen And Codeine20 in 1 BOTTLE, PLASTICTABLET203
33261-002-25Acetaminophen And Codeine25 in 1 BOTTLE, PLASTICTABLET253
33261-002-28Acetaminophen And Codeine28 in 1 BOTTLE, PLASTICTABLET283
33261-002-30Acetaminophen And Codeine30 in 1 BOTTLE, PLASTICTABLET303
33261-002-40Acetaminophen And Codeine40 in 1 BOTTLE, PLASTICTABLET403
33261-002-50Acetaminophen And Codeine50 in 1 BOTTLE, PLASTICTABLET503
33261-002-60Acetaminophen And Codeine60 in 1 BOTTLE, PLASTICTABLET603
33261-002-90Acetaminophen And Codeine90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-002-02EA - Each33261-0021f623740-5e0d-4f59-ab27-1301ba0edc9c12015-10-02
33261-002-10EA - Each33261-002060f030b-d2be-4ee9-82cf-2c9b7e7810ab12015-10-02
33261-002-12EA - Each33261-00254a7398b-47e0-47bd-80fe-f59dc153d8c712015-10-02
33261-002-14EA - Each33261-00263846935-b0ea-4290-b889-53bd006ecda512015-10-02
33261-002-20EA - Each33261-0021fefe30a-b3e0-4b73-bcbc-512240cbcd3112015-10-02
33261-002-28EA - Each33261-0026c31c915-4251-408f-9537-d92b677654ed12015-10-02
33261-002-30EA - Each33261-00215f64717-5e78-40b0-8c5a-63bd1d12f87212015-10-02
33261-002-40EA - Each33261-0024559a01d-1d59-4ebc-8f12-e8ac6146fa8712015-10-02
33261-002-60EA - Each33261-0022738c745-b557-4b00-badf-5b417e6133e112015-10-02
33261-002-90EA - Each33261-0020175fe56-a7ef-471b-88da-f2c19ad974e212015-10-02

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
33261-002ACETAMINOPHEN 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
33261-002-0233261000202120 in 1 BOTTLE, PLASTICHistorical
33261-002-103326100021010 in 1 BOTTLE, PLASTICHistorical
33261-002-123326100021212 in 1 BOTTLE, PLASTICHistorical
33261-002-143326100021414 in 1 BOTTLE, PLASTICHistorical
33261-002-153326100021515 in 1 BOTTLE, PLASTICHistorical
33261-002-203326100022020 in 1 BOTTLE, PLASTICHistorical
33261-002-253326100022525 in 1 BOTTLE, PLASTICHistorical
33261-002-283326100022828 in 1 BOTTLE, PLASTICHistorical
33261-002-303326100023030 in 1 BOTTLE, PLASTICHistorical
33261-002-403326100024040 in 1 BOTTLE, PLASTICHistorical
33261-002-503326100025050 in 1 BOTTLE, PLASTICHistorical
33261-002-603326100026060 in 1 BOTTLE, PLASTICHistorical
33261-002-903326100029090 in 1 BOTTLE, PLASTICHistorical