FDA.reportPublic FDA data

Acetaminophen And Codeine

Product NDC
66336-059
11-digit product format
663360059
Labeler code
66336
Product ID
66336-059_30993951-a2b3-4106-9ff1-639c17d8ff0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
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
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2017-12-31
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
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66336-059-062019-11-13C16284748780-197449f38-bf21-f6ea-e053-dbdaa90aa703ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
66336-059-102019-11-13C16284748780-197449f38-bf21-f6ea-e053-dbdaa90aa703ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
66336-059-122019-11-13C16284748780-197449f38-bf21-f6ea-e053-dbdaa90aa703ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
66336-059-152019-11-13C16284748780-197449f38-bf21-f6ea-e053-dbdaa90aa703ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
66336-059-162019-11-13C16284748780-197449f38-bf21-f6ea-e053-dbdaa90aa703ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
66336-059-202019-11-13C16284748780-197449f38-bf21-f6ea-e053-dbdaa90aa703ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
66336-059-242019-11-13C16284748780-197449f38-bf21-f6ea-e053-dbdaa90aa703ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
66336-059-302019-11-13C16284748780-197449f38-bf21-f6ea-e053-dbdaa90aa703ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
66336-059-402019-11-13C16284748780-197449f38-bf21-f6ea-e053-dbdaa90aa703ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
66336-059-602019-11-13C16284748780-197449f38-bf21-f6ea-e053-dbdaa90aa703ACETAMINOPHEN 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
66336-059-06Acetaminophen And Codeine6 in 1 BOTTLETABLET62
66336-059-10Acetaminophen And Codeine10 in 1 BOTTLETABLET102
66336-059-12Acetaminophen And Codeine12 in 1 BOTTLETABLET122
66336-059-15Acetaminophen And Codeine15 in 1 BOTTLETABLET152
66336-059-16Acetaminophen And Codeine16 in 1 BOTTLETABLET162
66336-059-20Acetaminophen And Codeine20 in 1 BOTTLETABLET202
66336-059-24Acetaminophen And Codeine24 in 1 BOTTLETABLET242
66336-059-30Acetaminophen And Codeine30 in 1 BOTTLETABLET302
66336-059-40Acetaminophen And Codeine40 in 1 BOTTLETABLET402
66336-059-60Acetaminophen And Codeine60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-059-10EA - Each66336-05988b80b28-3349-425c-956b-ee4b1b391f3412012-07-24
66336-059-12EA - Each66336-0593b23ab11-3a4c-4037-9af9-dea302f7411212012-07-24
66336-059-15EA - Each66336-05935dba59e-8a8a-4127-b8e5-26b08ce1281912012-07-24
66336-059-20EA - Each66336-0591369172c-edea-45a4-bf72-8502e412dc5312012-07-24
66336-059-30EA - Each66336-059b1ad96b2-a118-46c8-b725-4164689dbc8312012-07-24
66336-059-60EA - Each66336-059f594936b-7747-4547-b914-bca185d1b6be12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [DISPENSING SOLUTIONS, INC.]2
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [DISPENSING SOLUTIONS, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [DISPENSING SOLUTIONS, INC.]2
CODEINEACTIVE MOIETYQ830PW7520ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [DISPENSING SOLUTIONS, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [DISPENSING SOLUTIONS, INC.]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [DISPENSING SOLUTIONS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [DISPENSING SOLUTIONS, INC.]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [DISPENSING SOLUTIONS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-059ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 10 package rows20120209_fcf3ab6d-28fb-43d4-8a21-782c46e6dffe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNfcf3ab6d-28fb-43d4-8a21-782c46e6dffe2
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDfcf3ab6d-28fb-43d4-8a21-782c46e6dffe2
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYfcf3ab6d-28fb-43d4-8a21-782c46e6dffe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-059-06663360059066 in 1 BOTTLEHistorical
66336-059-106633600591010 in 1 BOTTLEHistorical
66336-059-126633600591212 in 1 BOTTLEHistorical
66336-059-156633600591515 in 1 BOTTLEHistorical
66336-059-166633600591616 in 1 BOTTLEHistorical
66336-059-206633600592020 in 1 BOTTLEHistorical
66336-059-246633600592424 in 1 BOTTLEHistorical
66336-059-306633600593030 in 1 BOTTLEHistorical
66336-059-406633600594040 in 1 BOTTLEHistorical
66336-059-606633600596060 in 1 BOTTLEHistorical