FDA.reportPublic FDA data

Acetaminophen and Codeine Phosphate

Product NDC
68071-4673
11-digit product format
680714673
Labeler code
68071
Product ID
68071-4673_1ab88e64-a058-9f93-e063-6294a90ab6a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202800
Marketing category
ANDA
Marketing start
2013-04-15
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300; 30 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen and Codeine Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN300 mg/1
CODEINE PHOSPHATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, GSL05Y1MN6
Rxcui993781

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
68071-4673-22023-07-12C16284748780-1ba0f9c33-39ba-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets, USP CIII
68071-4673-32023-07-12C16284748780-1ba0f9c33-39ba-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets, USP CIII
68071-4673-42023-07-12C16284748780-1ba0f9c33-39ba-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets, USP CIII
68071-4673-52023-07-12C16284748780-1ba0f9c33-39ba-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets, USP CIII
68071-4673-22023-01-30C16284748780-1ba0f9c33-39ba-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets, USP CIII
68071-4673-32023-01-30C16284748780-1ba0f9c33-39ba-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets, USP CIII
68071-4673-42023-01-30C16284748780-1ba0f9c33-39ba-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets, USP CIII
68071-4673-52023-01-30C16284748780-1ba0f9c33-39ba-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets, USP CIII
68071-4673-32021-02-10C16284748780-1ba0f9c33-39ba-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets, USP CIII
68071-4673-32021-01-29C16284748780-1ba0f9c33-39ba-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets, USP CIII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4673-2Acetaminophen and Codeine Phosphate20 in 1 BOTTLETABLET207
68071-4673-3Acetaminophen and Codeine Phosphate30 in 1 BOTTLETABLET307
68071-4673-4Acetaminophen and Codeine Phosphate24 in 1 BOTTLETABLET247
68071-4673-5Acetaminophen and Codeine Phosphate15 in 1 BOTTLETABLET157

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4673ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 4 package rows20240614_7d69403e-90d0-7a80-e053-2a91aa0a5552.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN7d69403e-90d0-7a80-e053-2a91aa0a55527
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD7d69403e-90d0-7a80-e053-2a91aa0a55527
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY7d69403e-90d0-7a80-e053-2a91aa0a55527

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4673-26807146730220 TABLET in 1 BOTTLE (68071-4673-2) 20 tablet2018-12-190000-00-00NoNoCurrent
68071-4673-36807146730330 TABLET in 1 BOTTLE (68071-4673-3) 30 tablet2018-12-190000-00-00NoNoCurrent
68071-4673-46807146730424 TABLET in 1 BOTTLE (68071-4673-4) 24 tablet2018-12-190000-00-00NoNoCurrent
68071-4673-56807146730515 TABLET in 1 BOTTLE (68071-4673-5) 15 tablet2018-12-190000-00-00NoNoCurrent