FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
61919-328
11-digit product format
619190328
Labeler code
61919
Product ID
61919-328_9c591e3e-8c8f-b0c4-e053-2995a90aea13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA088628
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
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
61919-328-302020-01-31C16284748780-19d75b9d0-79a8-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE
61919-328-712020-01-31C16284748780-19d75b9d0-79a8-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE
61919-328-902020-01-31C16284748780-19d75b9d0-79a8-f424-e053-dadaa90a57ceACETAMINOPHEN AND CODEINE PHOSPHATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-328-30ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BOTTLETABLET302
61919-328-71ACETAMINOPHEN AND CODEINE PHOSPHATE100 in 1 BOTTLETABLET1002
61919-328-90ACETAMINOPHEN AND CODEINE PHOSPHATE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-328-71EA - Each61919-3281fb2fe4e-1f44-415f-9817-4e20824aefa212016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT RX]2
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT RX]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT RX]2
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT RX]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-328ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT RX]2Legacy NDC, 3 package rows20150814_82824242-f42d-449d-8fdf-7e999e72a26c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN82824242-f42d-449d-8fdf-7e999e72a26c2
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD82824242-f42d-449d-8fdf-7e999e72a26c2
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY82824242-f42d-449d-8fdf-7e999e72a26c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-328-306191903283030 in 1 BOTTLEHistorical
61919-328-606191903286060 TABLET in 1 BOTTLE (61919-328-60) 60 tablet2019-07-120000-00-00NoNoCurrent
61919-328-7161919032871100 in 1 BOTTLEHistorical
61919-328-906191903289090 in 1 BOTTLEHistorical