FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
67544-002
11-digit product format
675440002
Labeler code
67544
Product ID
67544-002_c4cf2f28-c73e-4370-843e-487b7b42e077
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040419
Marketing category
ANDA
Marketing start
2011-07-06
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
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
67544-002-09ACETAMINOPHEN AND CODEINE PHOSPHATE9 in 1 BOTTLE, PLASTICTABLET95
67544-002-15ACETAMINOPHEN AND CODEINE PHOSPHATE15 in 1 BOTTLE, PLASTICTABLET155
67544-002-20ACETAMINOPHEN AND CODEINE PHOSPHATE20 in 1 BOTTLE, PLASTICTABLET205
67544-002-30ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BOTTLE, PLASTICTABLET305
67544-002-40ACETAMINOPHEN AND CODEINE PHOSPHATE40 in 1 BOTTLE, PLASTICTABLET405
67544-002-45ACETAMINOPHEN AND CODEINE PHOSPHATE45 in 1 BOTTLE, PLASTICTABLET455
67544-002-46ACETAMINOPHEN AND CODEINE PHOSPHATE56 in 1 BOTTLE, PLASTICTABLET565
67544-002-50ACETAMINOPHEN AND CODEINE PHOSPHATE50 in 1 BOTTLE, PLASTICTABLET505
67544-002-53ACETAMINOPHEN AND CODEINE PHOSPHATE60 in 1 BOTTLE, PLASTICTABLET605
67544-002-54ACETAMINOPHEN AND CODEINE PHOSPHATE84 in 1 BOTTLE, PLASTICTABLET845
67544-002-55ACETAMINOPHEN AND CODEINE PHOSPHATE75 in 1 BOTTLE, PLASTICTABLET755
67544-002-60ACETAMINOPHEN AND CODEINE PHOSPHATE90 in 1 BOTTLE, PLASTICTABLET905
67544-002-70ACETAMINOPHEN AND CODEINE PHOSPHATE120 in 1 BOTTLE, PLASTICTABLET1205
67544-002-72ACETAMINOPHEN AND CODEINE PHOSPHATE112 in 1 BOTTLE, PLASTICTABLET1125
67544-002-75ACETAMINOPHEN AND CODEINE PHOSPHATE150 in 1 BOTTLE, PLASTICTABLET1505
67544-002-80ACETAMINOPHEN AND CODEINE PHOSPHATE180 in 1 BOTTLE, PLASTICTABLET1805
67544-002-85ACETAMINOPHEN AND CODEINE PHOSPHATE200 in 1 BOTTLE, PLASTICTABLET2005
67544-002-90ACETAMINOPHEN AND CODEINE PHOSPHATE240 in 1 BOTTLE, PLASTICTABLET2405
67544-002-93ACETAMINOPHEN AND CODEINE PHOSPHATE300 in 1 BOTTLE, PLASTICTABLET3005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-002-15EA - Each67544-00296d5967b-4b01-41e6-9757-357495cbb11c12014-06-03
67544-002-20EA - Each67544-002f265494a-6aa8-4cd3-9d65-654f2d7f01d112014-06-03
67544-002-30EA - Each67544-002fed59c6a-3a03-4a0a-ab3e-f55c3a1e416f12014-06-03
67544-002-40EA - Each67544-0026bde1cc4-50e0-4657-947b-a825f03a72a812014-06-03
67544-002-45EA - Each67544-0025f9faf07-ae23-44da-b711-4ff7f7f9f99712014-06-03
67544-002-46EA - Each67544-002a8be8bf0-58de-4153-abea-d2f0aa6e3e5912021-09-07
67544-002-50EA - Each67544-002bb092ed9-690f-4857-ad84-61b424b4070512014-06-03
67544-002-53EA - Each67544-0028a31ce77-3667-4383-9d4a-b522eabb5d2212014-06-03
67544-002-54EA - Each67544-00213910e79-e001-4a21-9237-d2562a479d3212021-09-07
67544-002-55EA - Each67544-002dd0e221c-4730-498d-9dc7-bb8f5cfb2d6612014-06-03
67544-002-60EA - Each67544-002be6fd85a-f9a4-4ce1-ab2f-d9dbde14754512014-06-03
67544-002-70EA - Each67544-0022a8ef6d6-2f85-4092-b1da-3893f015340212014-06-03
67544-002-72EA - Each67544-002208db864-0bae-4f98-a32d-e6414ca6ed0812021-09-07
67544-002-75EA - Each67544-0028d8f2fda-8df1-45b5-ba76-6476c73c700c12014-06-03
67544-002-80EA - Each67544-0022302ea2a-9268-465b-8a41-58cbc9fe438c12014-06-03
67544-002-85EA - Each67544-002fa340a95-fdd6-43cd-8b9c-87bc586103ee12014-06-03
67544-002-90EA - Each67544-002f237aca3-47bb-45bd-a142-12011631121a12014-06-03
67544-002-93EA - Each67544-002cdf94354-1342-4a37-a6fa-7b2ea7c5e8a612014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-002ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]5Current NDC, Legacy NDC, 19 package rows20250110_d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993770codeine phosphate 15 MG / acetaminophen 300 MG Oral TabletPSNd53bf9b7-1652-4287-a0c1-e89f6f0cb7f15
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNd53bf9b7-1652-4287-a0c1-e89f6f0cb7f15
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSNd53bf9b7-1652-4287-a0c1-e89f6f0cb7f15
993770acetaminophen 300 MG / codeine phosphate 15 MG Oral TabletSCDd53bf9b7-1652-4287-a0c1-e89f6f0cb7f15
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDd53bf9b7-1652-4287-a0c1-e89f6f0cb7f15
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCDd53bf9b7-1652-4287-a0c1-e89f6f0cb7f15
993770APAP 300 MG / codeine phosphate 15 MG Oral TabletSYd53bf9b7-1652-4287-a0c1-e89f6f0cb7f15
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYd53bf9b7-1652-4287-a0c1-e89f6f0cb7f15
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSYd53bf9b7-1652-4287-a0c1-e89f6f0cb7f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-002-09675440002099 TABLET in 1 BOTTLE, PLASTIC (67544-002-09) 9 tablet2011-07-060000-00-00NoNoCurrent
67544-002-156754400021515 TABLET in 1 BOTTLE, PLASTIC (67544-002-15) 15 tablet2011-07-060000-00-00NoNoCurrent
67544-002-206754400022020 TABLET in 1 BOTTLE, PLASTIC (67544-002-20) 20 tablet2011-07-060000-00-00NoNoCurrent
67544-002-306754400023030 TABLET in 1 BOTTLE, PLASTIC (67544-002-30) 30 tablet2011-07-060000-00-00NoNoCurrent
67544-002-406754400024040 TABLET in 1 BOTTLE, PLASTIC (67544-002-40) 40 tablet2011-07-060000-00-00NoNoCurrent
67544-002-456754400024545 TABLET in 1 BOTTLE, PLASTIC (67544-002-45) 45 tablet2011-07-060000-00-00NoNoCurrent
67544-002-466754400024656 TABLET in 1 BOTTLE, PLASTIC (67544-002-46) 56 tablet2021-07-280000-00-00NoNoCurrent
67544-002-506754400025050 TABLET in 1 BOTTLE, PLASTIC (67544-002-50) 50 tablet2011-07-060000-00-00NoNoCurrent
67544-002-536754400025360 TABLET in 1 BOTTLE, PLASTIC (67544-002-53) 60 tablet2011-07-060000-00-00NoNoCurrent
67544-002-546754400025484 TABLET in 1 BOTTLE, PLASTIC (67544-002-54) 84 tablet2021-08-040000-00-00NoNoCurrent
67544-002-556754400025575 TABLET in 1 BOTTLE, PLASTIC (67544-002-55) 75 tablet2011-07-060000-00-00NoNoCurrent
67544-002-606754400026090 TABLET in 1 BOTTLE, PLASTIC (67544-002-60) 90 tablet2011-07-060000-00-00NoNoCurrent
67544-002-7067544000270120 TABLET in 1 BOTTLE, PLASTIC (67544-002-70) 120 tablet2011-07-060000-00-00NoNoCurrent
67544-002-7267544000272112 TABLET in 1 BOTTLE, PLASTIC (67544-002-72) 112 tablet2021-08-100000-00-00NoNoCurrent
67544-002-7567544000275150 TABLET in 1 BOTTLE, PLASTIC (67544-002-75) 150 tablet2011-07-060000-00-00NoNoCurrent
67544-002-8067544000280180 TABLET in 1 BOTTLE, PLASTIC (67544-002-80) 180 tablet2011-07-060000-00-00NoNoCurrent
67544-002-8567544000285200 TABLET in 1 BOTTLE, PLASTIC (67544-002-85) 200 tablet2011-07-060000-00-00NoNoCurrent
67544-002-9067544000290240 TABLET in 1 BOTTLE, PLASTIC (67544-002-90) 240 tablet2011-07-060000-00-00NoNoCurrent
67544-002-9367544000293300 TABLET in 1 BOTTLE, PLASTIC (67544-002-93) 300 tablet2011-07-060000-00-00NoNoCurrent