FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
71930-054
11-digit product format
719300054
Labeler code
71930
Product ID
71930-054_5818712b-07d5-490a-9e8d-e895077a807d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA211610
Marketing category
ANDA
Marketing start
2019-08-02
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300; 15 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACETAMINOPHEN AND CODEINE PHOSPHATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN300 mg/1
CODEINE PHOSPHATE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, GSL05Y1MN6
Rxcui993770, 993781, 993890

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71930-054-12ACETAMINOPHEN AND CODEINE PHOSPHATE100 in 1 BOTTLETABLET1008
71930-054-52ACETAMINOPHEN AND CODEINE PHOSPHATE500 in 1 BOTTLETABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-054-12EA - Each71930-0549859beb2-7e1d-4710-bfd7-97f6e8fa4de512019-09-05
71930-054-52EA - Each71930-054ff43b65f-2fe6-487a-a378-e39a2a89a93412019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-054ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [EYWA PHARMA INC]6Current NDC, Legacy NDC, 2 package rows20240906_79377617-686b-4640-b2b8-e1358cf82358.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993770codeine phosphate 15 MG / acetaminophen 300 MG Oral TabletPSN79377617-686b-4640-b2b8-e1358cf823588
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN79377617-686b-4640-b2b8-e1358cf823588
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSN79377617-686b-4640-b2b8-e1358cf823588
993770acetaminophen 300 MG / codeine phosphate 15 MG Oral TabletSCD79377617-686b-4640-b2b8-e1358cf823588
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD79377617-686b-4640-b2b8-e1358cf823588
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCD79377617-686b-4640-b2b8-e1358cf823588
993770APAP 300 MG / codeine phosphate 15 MG Oral TabletSY79377617-686b-4640-b2b8-e1358cf823588
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY79377617-686b-4640-b2b8-e1358cf823588
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSY79377617-686b-4640-b2b8-e1358cf823588

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71930-054-1271930005412100 TABLET in 1 BOTTLE (71930-054-12) 100 tablet2019-08-020000-00-00NoNoCurrent
71930-054-5271930005452500 TABLET in 1 BOTTLE (71930-054-52) 500 tablet2019-08-020000-00-00NoNoCurrent