FDA.reportPublic FDA data

Acetaminophen and Codeine Phosphate

Product NDC
64380-448
11-digit product format
643800448
Labeler code
64380
Product ID
64380-448_c87671eb-3ec7-4930-be25-5686a75679de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA089990
Marketing category
ANDA
Marketing start
2024-05-20
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300; 15 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
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 PHOSPHATE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, GSL05Y1MN6
Rxcui993770, 993781, 993890

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
64380-448-01Acetaminophen and Codeine Phosphate100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-448-01EA - Each64380-44891e454a4-f5c4-41f4-982c-578e3380cead12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-448ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [STRIDES PHARMA SCIENCE LIMITED]1Current NDC, 1 package rows20240520_c459ed02-afd6-4533-82b6-bfb2c7ab0e72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993770codeine phosphate 15 MG / acetaminophen 300 MG Oral TabletPSNc459ed02-afd6-4533-82b6-bfb2c7ab0e721
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNc459ed02-afd6-4533-82b6-bfb2c7ab0e721
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSNc459ed02-afd6-4533-82b6-bfb2c7ab0e721
993770acetaminophen 300 MG / codeine phosphate 15 MG Oral TabletSCDc459ed02-afd6-4533-82b6-bfb2c7ab0e721
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDc459ed02-afd6-4533-82b6-bfb2c7ab0e721
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCDc459ed02-afd6-4533-82b6-bfb2c7ab0e721
993770APAP 300 MG / codeine phosphate 15 MG Oral TabletSYc459ed02-afd6-4533-82b6-bfb2c7ab0e721
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYc459ed02-afd6-4533-82b6-bfb2c7ab0e721
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSYc459ed02-afd6-4533-82b6-bfb2c7ab0e721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64380-448-0164380044801100 TABLET in 1 BOTTLE (64380-448-01) 100 tablet2024-05-20NoNoCurrent