ACETAMINOPHEN AND CODEINE

Product NDC
61919-023
11-digit product format
619190023
Labeler code
61919
Product ID
61919-023_f200c107-50c1-39ae-e053-2995a90a2f9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN AND CODEINE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040779
Marketing category
ANDA
Marketing start
2014-01-01
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
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-023-602025-01-30C16284748780-12cef2736-9647-d83d-e063-dadaa90ab31fACETAMINOPHEN AND CODEINE
61919-023-902025-01-30C16284748780-12cef2736-9647-d83d-e063-dadaa90ab31fACETAMINOPHEN AND CODEINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-023-60ACETAMINOPHEN AND CODEINE60 in 1 BOTTLETABLET6015
61919-023-90ACETAMINOPHEN AND CODEINE90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-023-60EA - Each61919-023b463e74a-2971-477b-bf2c-aa8357e76fe612014-06-03
61919-023-90EA - Each61919-02311bb2c54-76f6-4c62-80ce-b47ffef12d1012019-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-023ACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]15Legacy NDC, 2 package rows20230331_720570a4-9eec-41c8-ae69-37189756c318.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-023-606191900236060 TABLET in 1 BOTTLE (61919-023-60) 60 tablet2015-09-010000-00-00NoNoCurrent
61919-023-906191900239090 TABLET in 1 BOTTLE (61919-023-90) 90 tablet2014-01-010000-00-00NoNoCurrent