FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
70518-3705
11-digit product format
705183705
Labeler code
70518
Product ID
70518-3705_49eb8635-aaa4-6e5f-e063-6394a90ab62d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040419
Marketing category
ANDA
Marketing start
2023-04-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACETAMINOPHEN AND CODEINE PHOSPHATE
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3705-0ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BLISTER PACKTABLET307
70518-3705-1ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BLISTER PACKTABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3705ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REMEDYREPACK INC.]5Current NDC, 2 package rows20250117_5c96d033-bf7c-47de-aa0d-5998b3bf4a63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN5c96d033-bf7c-47de-aa0d-5998b3bf4a637
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD5c96d033-bf7c-47de-aa0d-5998b3bf4a637
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY5c96d033-bf7c-47de-aa0d-5998b3bf4a637

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3705-07051837050030 TABLET in 1 BLISTER PACK (70518-3705-0) 30 tablet2023-04-10NoNoHistorical
70518-3705-17051837050130 TABLET in 1 BLISTER PACK (70518-3705-1) 30 tablet2026-02-02NoNoHistorical