FDA.reportPublic FDA data

Acetaminophen and Codeine Phosphate

Product NDC
63187-815
11-digit product format
631870815
Labeler code
63187
Product ID
63187-815_5dde8fb0-3744-4a96-89c4-5b891681ccd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202800
Marketing category
ANDA
Marketing start
2017-01-05
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
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 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
63187-815-15Acetaminophen and Codeine Phosphate15 in 1 BOTTLETABLET156
63187-815-20Acetaminophen and Codeine Phosphate20 in 1 BOTTLETABLET206
63187-815-30Acetaminophen and Codeine Phosphate30 in 1 BOTTLETABLET306
63187-815-60Acetaminophen and Codeine Phosphate60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-815-15EA - Each63187-8156f2f625e-43fb-4105-b2fb-a2fb38dddde812020-08-06
63187-815-20EA - Each63187-81539aedde1-6947-46dd-ab56-5a8e36541e4e12017-03-06
63187-815-30EA - Each63187-81598fcc02a-c937-4496-890f-c7bda9d76d1c12017-03-06
63187-815-60EA - Each63187-8152d409540-239d-49d0-8724-859863cfebce12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-815ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20220420_75b50751-5237-4e3e-b7ee-1605c0602f3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN75b50751-5237-4e3e-b7ee-1605c0602f3b6
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD75b50751-5237-4e3e-b7ee-1605c0602f3b6
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY75b50751-5237-4e3e-b7ee-1605c0602f3b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-815-156318708151515 TABLET in 1 BOTTLE (63187-815-15) 15 tablet2020-05-280000-00-00NoNoCurrent
63187-815-206318708152020 TABLET in 1 BOTTLE (63187-815-20) 20 tablet2017-02-010000-00-00NoNoCurrent
63187-815-306318708153030 TABLET in 1 BOTTLE (63187-815-30) 30 tablet2017-02-010000-00-00NoNoCurrent
63187-815-606318708156060 TABLET in 1 BOTTLE (63187-815-60) 60 tablet2017-02-010000-00-00NoNoCurrent