FDA.reportPublic FDA data

Acetaminophen And Codeine

Product NDC
67544-474
11-digit product format
675440474
Labeler code
67544
Product ID
67544-474_6a62ad9a-c0ce-4848-81f3-159f525922a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA089828
Marketing category
ANDA
Marketing start
1988-09-30
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; ACETAMINOPHEN
Active strength
60 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67544-474-302023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-474-532023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-474-602023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-474-702023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-474-802023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-474-902023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-474-30Acetaminophen And Codeine30 in 1 BOTTLE, PLASTICTABLET302
67544-474-53Acetaminophen And Codeine60 in 1 BOTTLE, PLASTICTABLET602
67544-474-60Acetaminophen And Codeine90 in 1 BOTTLE, PLASTICTABLET902
67544-474-70Acetaminophen And Codeine120 in 1 BOTTLE, PLASTICTABLET1202
67544-474-80Acetaminophen And Codeine180 in 1 BOTTLE, PLASTICTABLET1802
67544-474-90Acetaminophen And Codeine240 in 1 BOTTLE, PLASTICTABLET2402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-474-53EA - Each67544-474cc8911ae-c711-4090-94da-c63f306505bd12014-07-02
67544-474-60EA - Each67544-47468702e37-ac15-4363-9dc5-325332a36d5f12014-07-02
67544-474-70EA - Each67544-47490b69837-763d-4190-9398-bf9ed8c729ea12014-09-03
67544-474-80EA - Each67544-47413f2dac9-d309-45bd-919a-d18b59a01e7c12013-07-02
67544-474-90EA - Each67544-4747cf11aee-e6ee-48aa-a8c2-23716aabd36b12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-474ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 6 package rows20191224_1afe1bb3-6903-4785-a121-ac8aae8653a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN1afe1bb3-6903-4785-a121-ac8aae8653a72
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSN1afe1bb3-6903-4785-a121-ac8aae8653a72
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD1afe1bb3-6903-4785-a121-ac8aae8653a72
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCD1afe1bb3-6903-4785-a121-ac8aae8653a72
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY1afe1bb3-6903-4785-a121-ac8aae8653a72
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSY1afe1bb3-6903-4785-a121-ac8aae8653a72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-474-306754404743030 TABLET in 1 BOTTLE, PLASTIC (67544-474-30) 30 tablet2007-08-140000-00-00NoNoCurrent
67544-474-536754404745360 TABLET in 1 BOTTLE, PLASTIC (67544-474-53) 60 tablet2005-11-170000-00-00NoNoCurrent
67544-474-606754404746090 TABLET in 1 BOTTLE, PLASTIC (67544-474-60) 90 tablet2005-12-020000-00-00NoNoCurrent
67544-474-7067544047470120 TABLET in 1 BOTTLE, PLASTIC (67544-474-70) 120 tablet2005-12-020000-00-00NoNoCurrent
67544-474-8067544047480180 TABLET in 1 BOTTLE, PLASTIC (67544-474-80) 180 tablet2012-10-160000-00-00NoNoCurrent
67544-474-9067544047490240 TABLET in 1 BOTTLE, PLASTIC (67544-474-90) 240 tablet2015-09-050000-00-00NoNoCurrent