Acetaminophen and Codeine

Product NDC
65162-033
11-digit product format
651620033
Labeler code
65162
Product ID
65162-033_75a6d334-42b8-44d0-a4a1-fd3eeb95008f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA040779
Marketing category
ANDA
Marketing start
2008-05-29
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
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
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-033-10Acetaminophen and Codeine100 in 1 BOTTLETABLET10046
65162-033-11Acetaminophen and Codeine1000 in 1 BOTTLETABLET100046
65162-033-50Acetaminophen and Codeine500 in 1 BOTTLETABLET50046

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-033-10EA - Each65162-033c3ea83ce-d04c-4f7a-9ecf-8b2211dbf70a12013-02-13
65162-033-11EA - Each65162-0339cadd470-f260-4cee-ae32-0ba16c1e325c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
CODEINEACTIVE INGREDIENTQ830PW7520ACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-033ACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS LLC]43Current NDC, Legacy NDC, 3 package rows20240228_8bc4108b-314e-4a52-a37c-631c6b869b04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN8bc4108b-314e-4a52-a37c-631c6b869b0446
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD8bc4108b-314e-4a52-a37c-631c6b869b0446
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY8bc4108b-314e-4a52-a37c-631c6b869b0446
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN720570a4-9eec-41c8-ae69-37189756c31815
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD720570a4-9eec-41c8-ae69-37189756c31815
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY720570a4-9eec-41c8-ae69-37189756c31815
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNc8284691-86f6-4ce0-b680-addc29b35fa613
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDc8284691-86f6-4ce0-b680-addc29b35fa613
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYc8284691-86f6-4ce0-b680-addc29b35fa613
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN7d940b9c-7406-4182-9052-c6a5806337a08
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD7d940b9c-7406-4182-9052-c6a5806337a08
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY7d940b9c-7406-4182-9052-c6a5806337a08
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN5970383b-06a3-45e7-9e93-41213a4f9b5d5
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNa35b4ba3-43c0-73c8-e053-2a95a90af5b55
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD5970383b-06a3-45e7-9e93-41213a4f9b5d5
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDa35b4ba3-43c0-73c8-e053-2a95a90af5b55
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY5970383b-06a3-45e7-9e93-41213a4f9b5d5
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYa35b4ba3-43c0-73c8-e053-2a95a90af5b55
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN2472bb8a-88b7-4eec-8806-34adef0c9ab94
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD2472bb8a-88b7-4eec-8806-34adef0c9ab94
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY2472bb8a-88b7-4eec-8806-34adef0c9ab94
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNb84d3e24-693d-4667-ae35-0583b63686103
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDb84d3e24-693d-4667-ae35-0583b63686103
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYb84d3e24-693d-4667-ae35-0583b63686103
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN57f985e3-9572-477f-e053-2991aa0a61c91
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN3f83ba75-9415-4ace-9416-04d666c005a21
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN894b2958-a67f-42bc-9b49-ba54008116951
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD894b2958-a67f-42bc-9b49-ba54008116951
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD3f83ba75-9415-4ace-9416-04d666c005a21
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD57f985e3-9572-477f-e053-2991aa0a61c91
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY3f83ba75-9415-4ace-9416-04d666c005a21
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY894b2958-a67f-42bc-9b49-ba54008116951
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY57f985e3-9572-477f-e053-2991aa0a61c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-033-1065162003310100 TABLET in 1 BOTTLE (65162-033-10) 100 tablet2008-05-290000-00-00NoNoCurrent
65162-033-11651620033111000 TABLET in 1 BOTTLE (65162-033-11) 1000 tablet2008-05-290000-00-00NoNoCurrent
65162-033-5065162003350500 TABLET in 1 BOTTLE (65162-033-50) 500 tablet2008-05-290000-00-00NoNoCurrent