FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
68071-4475
11-digit product format
680714475
Labeler code
68071
Product ID
68071-4475_1a8d7399-1a61-5895-e063-6394a90aaeca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040419
Marketing category
ANDA
Marketing start
2011-07-06
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

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
68071-4475-22021-02-10C16284748780-1ba0f9c33-238d-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4475-42021-02-10C16284748780-1ba0f9c33-238d-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4475-62021-02-10C16284748780-1ba0f9c33-238d-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4475-22021-01-29C16284748780-1ba0f9c33-238d-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4475-42021-01-29C16284748780-1ba0f9c33-238d-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4475-62021-01-29C16284748780-1ba0f9c33-238d-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4475-2ACETAMINOPHEN AND CODEINE PHOSPHATE12 in 1 BOTTLETABLET125
68071-4475-4ACETAMINOPHEN AND CODEINE PHOSPHATE4 in 1 BOTTLETABLET45
68071-4475-6ACETAMINOPHEN AND CODEINE PHOSPHATE6 in 1 BOTTLETABLET65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4475ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 3 package rows20240612_6f2ce909-6356-1c2c-e053-2a91aa0a0135.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN6f2ce909-6356-1c2c-e053-2a91aa0a01355
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD6f2ce909-6356-1c2c-e053-2a91aa0a01355
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY6f2ce909-6356-1c2c-e053-2a91aa0a01355

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4475-26807144750212 TABLET in 1 BOTTLE (68071-4475-2) 12 tablet2018-06-210000-00-00NoNoCurrent
68071-4475-4680714475044 TABLET in 1 BOTTLE (68071-4475-4) 4 tablet2018-06-210000-00-00NoNoCurrent
68071-4475-6680714475066 TABLET in 1 BOTTLE (68071-4475-6) 6 tablet2018-06-210000-00-00NoNoCurrent