FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
71335-1846
11-digit product format
713351846
Labeler code
71335
Product ID
71335-1846_6c7258ab-22b9-49e0-b78c-46732502c212
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
71335-1846-0ACETAMINOPHEN AND CODEINE PHOSPHATE100 in 1 BOTTLETABLET100103
71335-1846-1ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BOTTLETABLET30103
71335-1846-2ACETAMINOPHEN AND CODEINE PHOSPHATE120 in 1 BOTTLETABLET120103
71335-1846-3ACETAMINOPHEN AND CODEINE PHOSPHATE60 in 1 BOTTLETABLET60103
71335-1846-4ACETAMINOPHEN AND CODEINE PHOSPHATE90 in 1 BOTTLETABLET90103
71335-1846-5ACETAMINOPHEN AND CODEINE PHOSPHATE40 in 1 BOTTLETABLET40103
71335-1846-6ACETAMINOPHEN AND CODEINE PHOSPHATE20 in 1 BOTTLETABLET20103
71335-1846-7ACETAMINOPHEN AND CODEINE PHOSPHATE112 in 1 BOTTLETABLET112103
71335-1846-8ACETAMINOPHEN AND CODEINE PHOSPHATE84 in 1 BOTTLETABLET84103
71335-1846-9ACETAMINOPHEN AND CODEINE PHOSPHATE15 in 1 BOTTLETABLET15103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1846-0EA - Each71335-1846e93c806d-bcfc-473c-9888-42ac9e3662f812026-03-17
71335-1846-1EA - Each71335-184641fe2de4-3b6d-452a-992c-28cfbf0f654912026-03-17
71335-1846-2EA - Each71335-18465c75e855-94c9-4af5-9358-71fa8b1ffd4212026-03-17
71335-1846-3EA - Each71335-1846ee38c3e5-1051-4527-8bbe-cc465a1cfd6412026-03-17
71335-1846-4EA - Each71335-18463be3f055-0d7b-42b9-8986-3150125bd42c12025-11-13
71335-1846-5EA - Each71335-184662082969-8f79-4743-8215-017742c3571212026-03-17
71335-1846-6EA - Each71335-1846ffff854c-ebb1-4a34-b0b0-ff490facbcef12026-03-17
71335-1846-7EA - Each71335-184602774ed6-8630-45a1-a5ed-192b4a338deb12026-03-17
71335-1846-8EA - Each71335-1846b61e96b4-9427-40b1-b1c5-1a41977e342612026-03-17
71335-1846-9EA - Each71335-184689f6fde1-d1fd-4443-b550-709db39c99bc12026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1846ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20241023_ff77a959-c77a-4911-8f7c-e2a3e24a6305.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSNff77a959-c77a-4911-8f7c-e2a3e24a6305103
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCDff77a959-c77a-4911-8f7c-e2a3e24a6305103
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSYff77a959-c77a-4911-8f7c-e2a3e24a6305103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1846-071335184600100 TABLET in 1 BOTTLE (71335-1846-0) 100 tablet2024-10-070000-00-00NoNoCurrent
71335-1846-17133518460130 TABLET in 1 BOTTLE (71335-1846-1) 30 tablet2021-07-070000-00-00NoNoCurrent
71335-1846-271335184602120 TABLET in 1 BOTTLE (71335-1846-2) 120 tablet2024-10-070000-00-00NoNoCurrent
71335-1846-37133518460360 TABLET in 1 BOTTLE (71335-1846-3) 60 tablet2021-06-150000-00-00NoNoCurrent
71335-1846-47133518460490 TABLET in 1 BOTTLE (71335-1846-4) 90 tablet2021-06-150000-00-00NoNoCurrent
71335-1846-57133518460540 TABLET in 1 BOTTLE (71335-1846-5) 40 tablet2024-10-070000-00-00NoNoCurrent
71335-1846-67133518460620 TABLET in 1 BOTTLE (71335-1846-6) 20 tablet2024-10-070000-00-00NoNoCurrent
71335-1846-771335184607112 TABLET in 1 BOTTLE (71335-1846-7) 112 tablet2024-10-070000-00-00NoNoCurrent
71335-1846-87133518460884 TABLET in 1 BOTTLE (71335-1846-8) 84 tablet2024-10-070000-00-00NoNoCurrent
71335-1846-97133518460915 TABLET in 1 BOTTLE (71335-1846-9) 15 tablet2024-10-070000-00-00NoNoCurrent