FDA.reportPublic FDA data

Acetaminophen and Codeine

Product NDC
52959-446
11-digit product format
529590446
Labeler code
52959
Product ID
52959-446_75c9fa2e-a170-69f7-e053-2a91aa0ad11a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA202800
Marketing category
ANDA
Marketing start
1997-05-23
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2019-12-31
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
52959-446-002020-01-31C16284748780-19d75b9d0-e7ee-f424-e053-dadaa90a57ce0003/0446
52959-446-022020-01-31C16284748780-19d75b9d0-e7ee-f424-e053-dadaa90a57ce0003/0446
52959-446-152020-01-31C16284748780-19d75b9d0-e7ee-f424-e053-dadaa90a57ce0003/0446
52959-446-202020-01-31C16284748780-19d75b9d0-e7ee-f424-e053-dadaa90a57ce0003/0446
52959-446-242020-01-31C16284748780-19d75b9d0-e7ee-f424-e053-dadaa90a57ce0003/0446
52959-446-302020-01-31C16284748780-19d75b9d0-e7ee-f424-e053-dadaa90a57ce0003/0446
52959-446-602020-01-31C16284748780-19d75b9d0-e7ee-f424-e053-dadaa90a57ce0003/0446
52959-446-902020-01-31C16284748780-19d75b9d0-e7ee-f424-e053-dadaa90a57ce0003/0446

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-446-00Acetaminophen and Codeine100 in 1 BOTTLETABLET1004
52959-446-02Acetaminophen and Codeine120 in 1 BOTTLETABLET1204
52959-446-15Acetaminophen and Codeine15 in 1 BOTTLETABLET154
52959-446-20Acetaminophen and Codeine20 in 1 BOTTLETABLET204
52959-446-24Acetaminophen and Codeine24 in 1 BOTTLETABLET244
52959-446-30Acetaminophen and Codeine30 in 1 BOTTLETABLET304
52959-446-60Acetaminophen and Codeine60 in 1 BOTTLETABLET604
52959-446-90Acetaminophen and Codeine90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-446-00EA - Each52959-446dfa23630-359d-4906-b0ab-fd0439951c2912018-10-11
52959-446-02EA - Each52959-446ba85264f-b9d2-4d40-b07a-82d5d9503eac12018-10-11
52959-446-20EA - Each52959-4463d88c52c-98a4-41c4-b1e1-45161c64e15012018-10-11
52959-446-24EA - Each52959-446a20cc0cf-4e22-4cd6-aa48-bfb363cc0e7e12018-10-11
52959-446-30EA - Each52959-4469b17abf4-c6ae-482b-91d3-cf8f1a2d247d12018-10-11
52959-446-60EA - Each52959-44617fa2b48-7926-4b62-80d8-372d0de779e512018-10-11
52959-446-90EA - Each52959-44666739157-7f80-4cac-930f-5300cd58838d12018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
CODEINEACTIVE MOIETYQ830PW7520ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-446ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [H.J. HARKINS COMPANY, INC.]4Legacy NDC, 8 package rows20180915_97b0ee29-d08e-4d9b-82ed-3ce287dbec28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN97b0ee29-d08e-4d9b-82ed-3ce287dbec284
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSN97b0ee29-d08e-4d9b-82ed-3ce287dbec284
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD97b0ee29-d08e-4d9b-82ed-3ce287dbec284
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCD97b0ee29-d08e-4d9b-82ed-3ce287dbec284
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY97b0ee29-d08e-4d9b-82ed-3ce287dbec284
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSY97b0ee29-d08e-4d9b-82ed-3ce287dbec284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-446-0052959044600100 in 1 BOTTLEHistorical
52959-446-0252959044602120 in 1 BOTTLEHistorical
52959-446-155295904461515 in 1 BOTTLEHistorical
52959-446-205295904462020 in 1 BOTTLEHistorical
52959-446-245295904462424 in 1 BOTTLEHistorical
52959-446-305295904463030 in 1 BOTTLEHistorical
52959-446-605295904466060 in 1 BOTTLEHistorical
52959-446-905295904469090 in 1 BOTTLEHistorical