FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
72162-2002
11-digit product format
721622002
Labeler code
72162
Product ID
72162-2002_5c55c1fc-0d42-4f81-a331-f69fe5882ed6
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; 60 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 PHOSPHATE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, GSL05Y1MN6
Rxcui993890

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
72162-2002-1ACETAMINOPHEN AND CODEINE PHOSPHATE100 in 1 BOTTLETABLET100103
72162-2002-5ACETAMINOPHEN AND CODEINE PHOSPHATE500 in 1 BOTTLETABLET500103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2002-1EA - Each72162-2002d7b4f4c2-d259-47cc-9aff-523a3b3fa97412023-12-05
72162-2002-5EA - Each72162-2002582ff66a-d3df-453e-94be-169ab55f553812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2002ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20241017_e73b17c4-9f24-4b32-8920-61c58c40a714.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSNe73b17c4-9f24-4b32-8920-61c58c40a714103
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCDe73b17c4-9f24-4b32-8920-61c58c40a714103
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSYe73b17c4-9f24-4b32-8920-61c58c40a714103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2002-172162200201100 TABLET in 1 BOTTLE (72162-2002-1) 100 tablet2019-08-02NoNoCurrent
72162-2002-572162200205500 TABLET in 1 BOTTLE (72162-2002-5) 500 tablet2019-08-02NoNoCurrent