FDA.reportPublic FDA data

Acetaminophen And Codeine

Product NDC
68387-250
11-digit product format
683870250
Labeler code
68387
Product ID
68387-250_813e328e-b953-413e-b467-33e71b9211db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA089805
Marketing category
ANDA
Marketing start
2009-03-19
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300 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
68387-250-152019-10-21C16284748780-1956f9ecf-caec-621f-e053-dbdaa90a74adACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
68387-250-302019-10-21C16284748780-1956f9ecf-caec-621f-e053-dbdaa90a74adACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
68387-250-402019-10-21C16284748780-1956f9ecf-caec-621f-e053-dbdaa90a74adACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
68387-250-602019-10-21C16284748780-1956f9ecf-caec-621f-e053-dbdaa90a74adACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
68387-250-902019-10-21C16284748780-1956f9ecf-caec-621f-e053-dbdaa90a74adACETAMINOPHEN 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
68387-250-15Acetaminophen And Codeine15 in 1 BOTTLE, PLASTICTABLET151
68387-250-30Acetaminophen And Codeine30 in 1 BOTTLE, PLASTICTABLET301
68387-250-40Acetaminophen And Codeine40 in 1 BOTTLE, PLASTICTABLET401
68387-250-60Acetaminophen And Codeine60 in 1 BOTTLE, PLASTICTABLET601
68387-250-90Acetaminophen And Codeine90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-250-15EA - Each68387-250dcda74f1-7378-4e6f-a5b5-956419807c3f12012-07-24
68387-250-30EA - Each68387-250abe128bf-84df-4a61-91b8-b8be72bf0cce12012-07-24
68387-250-40EA - Each68387-250e725a4c5-6136-42e0-832c-252d3a123a2c12012-07-24
68387-250-60EA - Each68387-250a123d93c-2edf-4ce2-a094-49ee05e089c212012-07-24
68387-250-90EA - Each68387-250bc963cac-1e20-4e71-ae94-d99eac9f7cdd12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-250ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [KELTMAN PHARMACEUTICALS INC.]1Legacy NDC, 5 package rows20100810_f94eb4bf-c577-4fa3-bfba-a12a6b821174.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNf94eb4bf-c577-4fa3-bfba-a12a6b8211741
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDf94eb4bf-c577-4fa3-bfba-a12a6b8211741
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYf94eb4bf-c577-4fa3-bfba-a12a6b8211741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-250-156838702501515 in 1 BOTTLE, PLASTICHistorical
68387-250-306838702503030 in 1 BOTTLE, PLASTICHistorical
68387-250-406838702504040 in 1 BOTTLE, PLASTICHistorical
68387-250-606838702506060 in 1 BOTTLE, PLASTICHistorical
68387-250-906838702509090 in 1 BOTTLE, PLASTICHistorical