FDA.reportPublic FDA data

Acetaminophen And Codeine

Product NDC
67544-882
11-digit product format
675440882
Labeler code
67544
Product ID
67544-882_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
ANDA089805
Marketing category
ANDA
Marketing start
1988-09-30
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; ACETAMINOPHEN
Active strength
30 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
67544-882-152023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-882-202023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-882-302023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-882-402023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-882-452023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-882-502023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-882-532023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-882-552023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-882-602023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-882-702023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-882-752023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-882-802023-01-30C16284748780-1f386c649-cc3d-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-882-902023-01-30C16284748780-1f386c649-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
67544-882-15Acetaminophen And Codeine15 in 1 BOTTLE, PLASTICTABLET152
67544-882-20Acetaminophen And Codeine20 in 1 BOTTLE, PLASTICTABLET202
67544-882-30Acetaminophen And Codeine30 in 1 BOTTLE, PLASTICTABLET302
67544-882-40Acetaminophen And Codeine40 in 1 BOTTLE, PLASTICTABLET402
67544-882-45Acetaminophen And Codeine45 in 1 BOTTLE, PLASTICTABLET452
67544-882-50Acetaminophen And Codeine50 in 1 BOTTLE, PLASTICTABLET502
67544-882-53Acetaminophen And Codeine60 in 1 BOTTLE, PLASTICTABLET602
67544-882-55Acetaminophen And Codeine75 in 1 BOTTLE, PLASTICTABLET752
67544-882-60Acetaminophen And Codeine90 in 1 BOTTLE, PLASTICTABLET902
67544-882-70Acetaminophen And Codeine120 in 1 BOTTLE, PLASTICTABLET1202
67544-882-75Acetaminophen And Codeine150 in 1 BOTTLE, PLASTICTABLET1502
67544-882-80Acetaminophen And Codeine180 in 1 BOTTLE, PLASTICTABLET1802
67544-882-90Acetaminophen And Codeine240 in 1 BOTTLE, PLASTICTABLET2402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-882-20EA - Each67544-882fe6ecb93-4559-49d6-bebc-605d4b69c77812013-07-02
67544-882-30EA - Each67544-88280b9852b-8d0b-4f62-8f85-e73dda52990712013-07-02
67544-882-40EA - Each67544-8820b19d9d6-c739-486f-bc9e-7c7932efee7412013-07-02
67544-882-45EA - Each67544-882b66cba2b-9079-4a8c-b1bb-816742a64ffa12013-07-02
67544-882-50EA - Each67544-882f7110da2-e0b7-4fb9-9d09-0d9524bac7f412015-05-05
67544-882-53EA - Each67544-8821d4c95f8-2aea-4488-8a76-bd12fa5cd2a712013-07-02
67544-882-55EA - Each67544-882a51710fa-c4d1-40ab-81c8-91db498ed26b12013-07-02
67544-882-60EA - Each67544-88206ae1dd6-4038-49c8-956a-55b4ecc2127c12013-07-02
67544-882-70EA - Each67544-882abd21761-0ad6-42ad-b21d-7f7716e2bb3512013-07-02
67544-882-75EA - Each67544-88206000e16-60cc-4634-b91d-408014cbf9b712016-04-04
67544-882-80EA - Each67544-882a73ec56a-502f-4e21-a3fb-2795d2b05c2d12013-07-02
67544-882-90EA - Each67544-882d2aeafc0-5dbd-4943-8adf-5c183442759112013-07-02

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
67544-882ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 13 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
67544-882-156754408821515 TABLET in 1 BOTTLE, PLASTIC (67544-882-15) 15 tablet2007-12-200000-00-00NoNoCurrent
67544-882-206754408822020 TABLET in 1 BOTTLE, PLASTIC (67544-882-20) 20 tablet2007-11-010000-00-00NoNoCurrent
67544-882-306754408823030 TABLET in 1 BOTTLE, PLASTIC (67544-882-30) 30 tablet2007-02-280000-00-00NoNoCurrent
67544-882-406754408824040 TABLET in 1 BOTTLE, PLASTIC (67544-882-40) 40 tablet2007-11-080000-00-00NoNoCurrent
67544-882-456754408824545 TABLET in 1 BOTTLE, PLASTIC (67544-882-45) 45 tablet2007-12-130000-00-00NoNoCurrent
67544-882-506754408825050 TABLET in 1 BOTTLE, PLASTIC (67544-882-50) 50 tablet2007-11-010000-00-00NoNoCurrent
67544-882-536754408825360 TABLET in 1 BOTTLE, PLASTIC (67544-882-53) 60 tablet2007-11-010000-00-00NoNoCurrent
67544-882-556754408825575 TABLET in 1 BOTTLE, PLASTIC (67544-882-55) 75 tablet2007-11-080000-00-00NoNoCurrent
67544-882-606754408826090 TABLET in 1 BOTTLE, PLASTIC (67544-882-60) 90 tablet2007-11-010000-00-00NoNoCurrent
67544-882-7067544088270120 TABLET in 1 BOTTLE, PLASTIC (67544-882-70) 120 tablet2007-11-010000-00-00NoNoCurrent
67544-882-7567544088275150 TABLET in 1 BOTTLE, PLASTIC (67544-882-75) 150 tablet2007-11-080000-00-00NoNoCurrent
67544-882-8067544088280180 TABLET in 1 BOTTLE, PLASTIC (67544-882-80) 180 tablet2007-11-010000-00-00NoNoCurrent
67544-882-9067544088290240 TABLET in 1 BOTTLE, PLASTIC (67544-882-90) 240 tablet2007-12-050000-00-00NoNoCurrent