ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
61919-053
11-digit product format
619190053
Labeler code
61919
Product ID
61919-053_9c591dec-4d4c-c000-e053-2a95a90a6b67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA202800
Marketing category
ANDA
Marketing start
2019-07-12
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-053-302023-01-30C16284748780-1f386c649-b207-0266-e053-dadaa90a7c1aAPAP CODEINE C-III
61919-053-602023-01-30C16284748780-1f386c64a-1cd4-0266-e053-dadaa90a7c1aAPAP CODEINE C-III
61919-053-712023-01-30C16284748780-1f386c64a-26ea-0266-e053-dadaa90a7c1aAPAP CODEINE C-III

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-053-30ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BOTTLETABLET302
61919-053-60ACETAMINOPHEN AND CODEINE PHOSPHATE60 in 1 BOTTLETABLET602
61919-053-71ACETAMINOPHEN AND CODEINE PHOSPHATE100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-053-60EA - Each61919-0532d36ce21-dc88-425c-8592-bf509fbc245912017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-053ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT RX]2Legacy NDC, 1 package rows20200123_486aa4c5-d307-48e7-e054-00144ff88e88.zip
61919-053ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20200123_8d80d5fd-7863-c551-e053-2995a90af2a9.zip
61919-053ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20200118_8d812c2b-15a6-4b6d-e053-2a95a90a889a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN486aa4c5-d307-48e7-e054-00144ff88e882
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN8d80d5fd-7863-c551-e053-2995a90af2a92
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN8d812c2b-15a6-4b6d-e053-2a95a90a889a2
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD486aa4c5-d307-48e7-e054-00144ff88e882
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD8d80d5fd-7863-c551-e053-2995a90af2a92
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD8d812c2b-15a6-4b6d-e053-2a95a90a889a2
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY486aa4c5-d307-48e7-e054-00144ff88e882
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY8d80d5fd-7863-c551-e053-2995a90af2a92
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY8d812c2b-15a6-4b6d-e053-2a95a90a889a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-053-306191900533030 TABLET in 1 BOTTLE (61919-053-30) 30 tablet2019-07-120000-00-00NoNoCurrent
61919-053-606191900536060 TABLET in 1 BOTTLE (61919-053-60) 60 tablet2017-02-130000-00-00NoNoCurrent
61919-053-7161919005371100 TABLET in 1 BOTTLE (61919-053-71) 100 tablet2019-07-120000-00-00NoNoCurrent