FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
49999-060
11-digit product format
499990060
Labeler code
49999
Product ID
49999-060_110c4c52-a3a4-4153-94e3-3a0be500d0ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA040419
Marketing category
ANDA
Marketing start
2011-09-14
Marketing end
2026-09-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACETAMINOPHEN AND CODEINE PHOSPHATE

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49999-060-00ACETAMINOPHEN AND CODEINE PHOSPHATE100 in 1 BOTTLETABLET1003394
49999-060-01ACETAMINOPHEN AND CODEINE PHOSPHATE120 in 1 BOTTLETABLET1203394
49999-060-06ACETAMINOPHEN AND CODEINE PHOSPHATE6 in 1 BOTTLETABLET63394
49999-060-10ACETAMINOPHEN AND CODEINE PHOSPHATE10 in 1 BOTTLETABLET103394
49999-060-12ACETAMINOPHEN AND CODEINE PHOSPHATE12 in 1 BOTTLETABLET123394
49999-060-15ACETAMINOPHEN AND CODEINE PHOSPHATE15 in 1 BOTTLETABLET153394
49999-060-20ACETAMINOPHEN AND CODEINE PHOSPHATE20 in 1 BOTTLETABLET203394
49999-060-24ACETAMINOPHEN AND CODEINE PHOSPHATE24 in 1 BOTTLETABLET243394
49999-060-30ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BOTTLETABLET303394
49999-060-50ACETAMINOPHEN AND CODEINE PHOSPHATE50 in 1 BOTTLETABLET503394
49999-060-60ACETAMINOPHEN AND CODEINE PHOSPHATE60 in 1 BOTTLETABLET603394
49999-060-90ACETAMINOPHEN AND CODEINE PHOSPHATE90 in 1 BOTTLETABLET903394

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-060-00EA - Each49999-060644d3396-2256-4f6a-9816-0538ecad0b0712012-07-24
49999-060-01EA - Each49999-060ee17e178-d93b-4659-ba96-e1e17931071d12012-07-24
49999-060-06EA - Each49999-060bccd3832-f680-44fc-b1ae-1a9e5461728812016-10-06
49999-060-10EA - Each49999-060c682267f-34bb-4d44-b0fd-520e3460a91512012-07-24
49999-060-12EA - Each49999-0605a0fd925-5215-46de-95b0-5e91f7019b7512012-07-24
49999-060-15EA - Each49999-060ac2dc670-53cc-4f7d-9c99-cf7f84b6537e12012-07-24
49999-060-20EA - Each49999-0602dace301-1c34-4a0c-81cb-ab6edbc3dd3712012-07-24
49999-060-24EA - Each49999-06063b1a7c4-386f-4b3d-bf30-c13e7dd5a5e212016-10-06
49999-060-30EA - Each49999-0606681467b-cb54-4374-8e3c-63faf1621b6812012-07-24
49999-060-50EA - Each49999-06009cd9a13-faec-4095-87ed-7721d99acbba12012-07-24
49999-060-60EA - Each49999-060cd5834ca-d490-4e58-8cc6-f9a294bae6b612012-07-24
49999-060-90EA - Each49999-06008aaea21-1e91-4bf1-be49-453084a1a70912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3385
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3385
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3385
CODEINEACTIVE MOIETYQ830PW7520ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3385

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49999-060ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [QUALITY CARE PRODUCTS, LLC]3394Current NDC, Legacy NDC, 12 package rows20241218_3b455938-7bbc-4626-939b-40b37709befb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN3b455938-7bbc-4626-939b-40b37709befb3394
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD3b455938-7bbc-4626-939b-40b37709befb3394
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY3b455938-7bbc-4626-939b-40b37709befb3394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49999-060-0049999006000100 TABLET in 1 BOTTLE (49999-060-00) 100 tablet2011-09-140000-00-00NoNoCurrent
49999-060-0149999006001120 TABLET in 1 BOTTLE (49999-060-01) 120 tablet2011-09-140000-00-00NoNoCurrent
49999-060-06499990060066 in 1 BOTTLEHistorical
49999-060-104999900601010 in 1 BOTTLEHistorical
49999-060-124999900601212 in 1 BOTTLEHistorical
49999-060-154999900601515 in 1 BOTTLEHistorical
49999-060-204999900602020 TABLET in 1 BOTTLE (49999-060-20) 20 tablet2011-09-140000-00-00NoNoCurrent
49999-060-244999900602424 TABLET in 1 BOTTLE (49999-060-24) 24 tablet2011-09-140000-00-00NoNoCurrent
49999-060-304999900603030 TABLET in 1 BOTTLE (49999-060-30) 30 tablet2011-09-140000-00-00NoNoCurrent
49999-060-504999900605050 TABLET in 1 BOTTLE (49999-060-50) 50 tablet2011-09-140000-00-00NoNoCurrent
49999-060-604999900606060 TABLET in 1 BOTTLE (49999-060-60) 60 tablet2011-09-142026-09-30NoNoCurrent
49999-060-904999900609090 TABLET in 1 BOTTLE (49999-060-90) 90 tablet2011-09-140000-00-00NoNoCurrent