ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
50090-4610
11-digit product format
500904610
Labeler code
50090
Product ID
50090-4610_a18dafdc-8a81-4129-bbc4-808083c24b23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040419
Marketing category
ANDA
Marketing start
2001-05-31
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300; 30 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIII
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 PHOSPHATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, GSL05Y1MN6
Rxcui993781

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
50090-4610-02023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-02023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-02023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-12023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-12023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-12023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-22023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-22023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-22023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-32023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-32023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-32023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-42023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-42023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-42023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-72023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-72023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-72023-09-21C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-02023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-02023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-02023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-12023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-12023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-12023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-22023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-22023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-22023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-32023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-32023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-32023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-42023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-42023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-42023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-72023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-72023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII
50090-4610-72023-01-30C16284748780-1f386c64a-146c-0266-e053-dadaa90a7c1aAcetaminophen and Codeine Phosphate Tablets USP CIII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4610-0ACETAMINOPHEN AND CODEINE PHOSPHATE10 in 1 BOTTLETABLET1012
50090-4610-1ACETAMINOPHEN AND CODEINE PHOSPHATE12 in 1 BOTTLETABLET1212
50090-4610-2ACETAMINOPHEN AND CODEINE PHOSPHATE15 in 1 BOTTLETABLET1512
50090-4610-3ACETAMINOPHEN AND CODEINE PHOSPHATE20 in 1 BOTTLETABLET2012
50090-4610-4ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BOTTLETABLET3012
50090-4610-7ACETAMINOPHEN AND CODEINE PHOSPHATE100 in 1 BOTTLETABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4610-0EA - Each50090-4610e2fa791f-2312-4fa8-8401-e186e997317012023-10-16
50090-4610-1EA - Each50090-4610ce793e4e-6d56-4262-91d5-3b5907af120712021-04-08
50090-4610-2EA - Each50090-4610737fec35-e2a6-482a-9590-bd6e1feb56c712023-10-16
50090-4610-3EA - Each50090-46103486e9d1-179b-4e32-8800-619ae1f9dd7712022-12-07
50090-4610-4EA - Each50090-461090054438-fb8a-4abd-acec-e32d5f6597c312023-10-16
50090-4610-7EA - Each50090-4610cbefaac3-f751-45a3-af85-d9eb9c136c9712023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4610ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 6 package rows20250221_dff53120-a609-4720-bd69-2391798c7dee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNdff53120-a609-4720-bd69-2391798c7dee12
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDdff53120-a609-4720-bd69-2391798c7dee12
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYdff53120-a609-4720-bd69-2391798c7dee12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4610-05009046100010 TABLET in 1 BOTTLE (50090-4610-0) 10 tablet2019-10-150000-00-00NoNoCurrent
50090-4610-15009046100112 TABLET in 1 BOTTLE (50090-4610-1) 12 tablet2019-10-150000-00-00NoNoCurrent
50090-4610-25009046100215 TABLET in 1 BOTTLE (50090-4610-2) 15 tablet2019-10-150000-00-00NoNoCurrent
50090-4610-35009046100320 TABLET in 1 BOTTLE (50090-4610-3) 20 tablet2019-10-150000-00-00NoNoCurrent
50090-4610-45009046100430 TABLET in 1 BOTTLE (50090-4610-4) 30 tablet2019-10-150000-00-00NoNoCurrent
50090-4610-750090461007100 TABLET in 1 BOTTLE (50090-4610-7) 100 tablet2019-10-150000-00-00NoNoCurrent