FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE

Product NDC
61919-484
11-digit product format
619190484
Labeler code
61919
Product ID
61919-484_2e805755-8d3f-0e94-e063-6294a90a7bc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN AND CODEINE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA040419
Marketing category
ANDA
Marketing start
2019-07-12
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACETAMINOPHEN AND CODEINE
Listing expiration
2026-12-31

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
61919-484-902025-05-02C16284748780-1f386c649-d2ca-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE
61919-484-182025-02-19C16284748780-12cef2736-7133-d83d-e063-dadaa90ab31fACETAMINOPHEN AND CODEINE
61919-484-302025-02-19C16284748780-12cef2736-7133-d83d-e063-dadaa90ab31fACETAMINOPHEN AND CODEINE
61919-484-712025-02-19C16284748780-12cef2736-7133-d83d-e063-dadaa90ab31fACETAMINOPHEN AND CODEINE
61919-484-182025-01-30C16284748780-12cef2736-7133-d83d-e063-dadaa90ab31fACETAMINOPHEN AND CODEINE
61919-484-302025-01-30C16284748780-12cef2736-7133-d83d-e063-dadaa90ab31fACETAMINOPHEN AND CODEINE
61919-484-712025-01-30C16284748780-12cef2736-7133-d83d-e063-dadaa90ab31fACETAMINOPHEN AND CODEINE
61919-484-602023-01-30C16284748780-1f386c64a-071c-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE
61919-484-902023-01-30C16284748780-1f386c649-d2ca-0266-e053-dadaa90a7c1aACETAMINOPHEN AND CODEINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-484-10ACETAMINOPHEN AND CODEINE10 in 1 BOTTLETABLET107
61919-484-18ACETAMINOPHEN AND CODEINE18 in 1 BOTTLETABLET187
61919-484-30ACETAMINOPHEN AND CODEINE30 in 1 BOTTLETABLET307
61919-484-71ACETAMINOPHEN AND CODEINE100 in 1 BOTTLETABLET1007
61919-484-90ACETAMINOPHEN AND CODEINE90 in 1 BOTTLETABLET902
61919-484-60ACETAMINOPHEN AND CODEINE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-484-10EA - Each61919-4844e04b85e-b29d-4a30-8967-fb12e9bc283612025-03-04
61919-484-18EA - Each61919-48405e44a6d-6078-4063-beb2-b46845cb50ca12022-04-06
61919-484-30EA - Each61919-484d5e7df74-5477-4461-8b53-179c459d6ea912018-04-19
61919-484-90EA - Each61919-484db5da418-31b0-4e4a-9b1b-418ae208285012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-484ACETAMINOPHEN AND CODEINE TABLET [DIRECT_RX]7Current NDC, Legacy NDC, 4 package rows20250221_8d7d6fa4-cc9f-6b4b-e053-2995a90a7286.zip
61919-484ACETAMINOPHEN AND CODEINE TABLET [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20250504_8d7ca633-4448-3507-e053-2a95a90a1287.zip
61919-484ACETAMINOPHEN AND CODEINE TABLET [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190713_8d7ca347-ad91-0ae1-e053-2995a90ac400.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN8d7d6fa4-cc9f-6b4b-e053-2995a90a72867
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD8d7d6fa4-cc9f-6b4b-e053-2995a90a72867
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY8d7d6fa4-cc9f-6b4b-e053-2995a90a72867
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN8d7ca633-4448-3507-e053-2a95a90a12872
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD8d7ca633-4448-3507-e053-2a95a90a12872
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY8d7ca633-4448-3507-e053-2a95a90a12872
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN8d7ca347-ad91-0ae1-e053-2995a90ac4001
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD8d7ca347-ad91-0ae1-e053-2995a90ac4001
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY8d7ca347-ad91-0ae1-e053-2995a90ac4001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-484-106191904841010 TABLET in 1 BOTTLE (61919-484-10) 10 tablet2019-07-12NoNoCurrent
61919-484-186191904841818 TABLET in 1 BOTTLE (61919-484-18) 18 tablet2019-07-120000-00-00NoNoCurrent
61919-484-306191904843030 TABLET in 1 BOTTLE (61919-484-30) 30 tablet2019-07-120000-00-00NoNoCurrent
61919-484-606191904846060 TABLET in 1 BOTTLE (61919-484-60) 60 tablet2019-07-120000-00-00NoNoCurrent
61919-484-7161919048471100 TABLET in 1 BOTTLE (61919-484-71) 100 tablet2019-07-120000-00-00NoNoCurrent
61919-484-906191904849090 TABLET in 1 BOTTLE (61919-484-90) 90 tablet2019-07-120000-00-00NoNoCurrent