FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
71335-1818
11-digit product format
713351818
Labeler code
71335
Product ID
71335-1818_c74c0d98-9483-405c-aab4-06c1cf181074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211610
Marketing category
ANDA
Marketing start
2019-08-02
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
71335-1818-0ACETAMINOPHEN AND CODEINE PHOSPHATE40 in 1 BOTTLETABLET40103
71335-1818-1ACETAMINOPHEN AND CODEINE PHOSPHATE6 in 1 BOTTLETABLET6103
71335-1818-2ACETAMINOPHEN AND CODEINE PHOSPHATE20 in 1 BOTTLETABLET20103
71335-1818-3ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BOTTLETABLET30103
71335-1818-4ACETAMINOPHEN AND CODEINE PHOSPHATE84 in 1 BOTTLETABLET84103
71335-1818-5ACETAMINOPHEN AND CODEINE PHOSPHATE15 in 1 BOTTLETABLET15103
71335-1818-6ACETAMINOPHEN AND CODEINE PHOSPHATE120 in 1 BOTTLETABLET120103
71335-1818-7ACETAMINOPHEN AND CODEINE PHOSPHATE100 in 1 BOTTLETABLET100103
71335-1818-8ACETAMINOPHEN AND CODEINE PHOSPHATE60 in 1 BOTTLETABLET60103
71335-1818-9ACETAMINOPHEN AND CODEINE PHOSPHATE90 in 1 BOTTLETABLET90103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1818-9EA - Each71335-18181993ea95-5e35-414a-a6a9-717f321aa79512022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1818ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20241023_f308fd07-f004-42de-963d-426b268bba93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNf308fd07-f004-42de-963d-426b268bba93103
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDf308fd07-f004-42de-963d-426b268bba93103
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYf308fd07-f004-42de-963d-426b268bba93103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1818-07133518180040 TABLET in 1 BOTTLE (71335-1818-0) 40 tablet2024-10-070000-00-00NoNoCurrent
71335-1818-1713351818016 TABLET in 1 BOTTLE (71335-1818-1) 6 tablet2024-10-070000-00-00NoNoCurrent
71335-1818-27133518180220 TABLET in 1 BOTTLE (71335-1818-2) 20 tablet2021-04-200000-00-00NoNoCurrent
71335-1818-37133518180330 TABLET in 1 BOTTLE (71335-1818-3) 30 tablet2021-04-210000-00-00NoNoCurrent
71335-1818-47133518180484 TABLET in 1 BOTTLE (71335-1818-4) 84 tablet2024-10-070000-00-00NoNoCurrent
71335-1818-57133518180515 TABLET in 1 BOTTLE (71335-1818-5) 15 tablet2021-05-040000-00-00NoNoCurrent
71335-1818-671335181806120 TABLET in 1 BOTTLE (71335-1818-6) 120 tablet2024-10-070000-00-00NoNoCurrent
71335-1818-771335181807100 TABLET in 1 BOTTLE (71335-1818-7) 100 tablet2021-03-250000-00-00NoNoCurrent
71335-1818-87133518180860 TABLET in 1 BOTTLE (71335-1818-8) 60 tablet2021-04-280000-00-00NoNoCurrent
71335-1818-97133518180990 TABLET in 1 BOTTLE (71335-1818-9) 90 tablet2021-04-290000-00-00NoNoCurrent