FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
21695-242
11-digit product format
216950242
Labeler code
21695
Product ID
21695-242_b0826efb-e191-4c84-a1cd-79306fe8ddf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA040419
Marketing category
ANDA
Marketing start
2009-06-29
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300 mg/1; mg/1
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2017-12-31
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
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
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
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
21695-242-122019-09-24C16284748780-1934fe258-4b45-48b1-e053-8cdaa90a720aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/30 mg, 300 mg/60 mg) CIII Rx only
21695-242-152019-09-24C16284748780-1934fe258-4b45-48b1-e053-8cdaa90a720aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/30 mg, 300 mg/60 mg) CIII Rx only
21695-242-182019-09-24C16284748780-1934fe258-4b45-48b1-e053-8cdaa90a720aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/30 mg, 300 mg/60 mg) CIII Rx only
21695-242-202019-09-24C16284748780-1934fe258-4b45-48b1-e053-8cdaa90a720aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/30 mg, 300 mg/60 mg) CIII Rx only
21695-242-282019-09-24C16284748780-1934fe258-4b45-48b1-e053-8cdaa90a720aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/30 mg, 300 mg/60 mg) CIII Rx only
21695-242-302019-09-24C16284748780-1934fe258-4b45-48b1-e053-8cdaa90a720aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/30 mg, 300 mg/60 mg) CIII Rx only
21695-242-402019-09-24C16284748780-1934fe258-4b45-48b1-e053-8cdaa90a720aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/30 mg, 300 mg/60 mg) CIII Rx only
21695-242-602019-09-24C16284748780-1934fe258-4b45-48b1-e053-8cdaa90a720aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/30 mg, 300 mg/60 mg) CIII Rx only
21695-242-902019-09-24C16284748780-1934fe258-4b45-48b1-e053-8cdaa90a720aACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/30 mg, 300 mg/60 mg) CIII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-242-12ACETAMINOPHEN AND CODEINE PHOSPHATE12 in 1 BOTTLETABLET121
21695-242-15ACETAMINOPHEN AND CODEINE PHOSPHATE15 in 1 BOTTLETABLET151
21695-242-18ACETAMINOPHEN AND CODEINE PHOSPHATE18 in 1 BOTTLETABLET181
21695-242-20ACETAMINOPHEN AND CODEINE PHOSPHATE20 in 1 BOTTLETABLET201
21695-242-28ACETAMINOPHEN AND CODEINE PHOSPHATE28 in 1 BOTTLETABLET281
21695-242-30ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BOTTLETABLET301
21695-242-40ACETAMINOPHEN AND CODEINE PHOSPHATE40 in 1 BOTTLETABLET401
21695-242-60ACETAMINOPHEN AND CODEINE PHOSPHATE60 in 1 BOTTLETABLET601
21695-242-90ACETAMINOPHEN AND CODEINE PHOSPHATE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-242-12EA - Each21695-242b8234f03-b894-4cd0-b2f4-0424437629d312013-02-13
21695-242-15EA - Each21695-242adb04fe5-d701-4614-b5f3-97395a735e1012013-02-13
21695-242-18EA - Each21695-242871b4fec-5086-4023-9f9e-ec539ff6b29412013-02-13
21695-242-20EA - Each21695-24296018ca1-dc8c-45c4-830b-da8d9769b27e12013-02-13
21695-242-28EA - Each21695-24273a17da4-61de-4b17-8aff-0c21d2ef9af212013-02-13
21695-242-30EA - Each21695-2427308ea22-16cd-4535-9566-b227cb775bc912013-02-13
21695-242-40EA - Each21695-242dbcc7311-5109-4bca-9663-703fc3bf2b0612013-02-13
21695-242-60EA - Each21695-242a451358d-3970-4fe5-bf27-5c4b455db13312013-02-13
21695-242-90EA - Each21695-2421e9a8375-a647-4e02-a686-489ad2e38b6a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REBEL DISTRIBUTORS CORP.]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REBEL DISTRIBUTORS CORP.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REBEL DISTRIBUTORS CORP.]1
CODEINEACTIVE MOIETYQ830PW7520ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REBEL DISTRIBUTORS CORP.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REBEL DISTRIBUTORS CORP.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REBEL DISTRIBUTORS CORP.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-242ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 9 package rows20091123_3c153389-4361-4a39-b7da-151ffc566f24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN3c153389-4361-4a39-b7da-151ffc566f241
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSN3c153389-4361-4a39-b7da-151ffc566f241
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD3c153389-4361-4a39-b7da-151ffc566f241
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCD3c153389-4361-4a39-b7da-151ffc566f241
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY3c153389-4361-4a39-b7da-151ffc566f241
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSY3c153389-4361-4a39-b7da-151ffc566f241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-242-122169502421212 in 1 BOTTLEHistorical
21695-242-152169502421515 in 1 BOTTLEHistorical
21695-242-182169502421818 in 1 BOTTLEHistorical
21695-242-202169502422020 in 1 BOTTLEHistorical
21695-242-282169502422828 in 1 BOTTLEHistorical
21695-242-302169502423030 in 1 BOTTLEHistorical
21695-242-402169502424040 in 1 BOTTLEHistorical
21695-242-602169502426060 in 1 BOTTLEHistorical
21695-242-902169502429090 in 1 BOTTLEHistorical