FDA.reportPublic FDA data

Acetaminophen and Codeine

Product NDC
71335-0545
11-digit product format
713350545
Labeler code
71335
Product ID
71335-0545_807a4459-2481-4325-a73e-a1e6bff4d5c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040779
Marketing category
ANDA
Marketing start
2008-05-29
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
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
71335-0545-02024-04-18C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-12024-04-18C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-22024-04-18C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-32024-04-18C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-42024-04-18C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-52024-04-18C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-62024-04-18C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-72024-04-18C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-82024-04-18C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-92024-04-18C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-02024-01-30C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-12024-01-30C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-22024-01-30C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-32024-01-30C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-42024-01-30C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-52024-01-30C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-62024-01-30C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-72024-01-30C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-82024-01-30C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
71335-0545-92024-01-30C16284748780-11030e365-3f1f-111a-e063-dadaa90a10e2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0545-0Acetaminophen and Codeine40 in 1 BOTTLETABLET408
71335-0545-1Acetaminophen and Codeine6 in 1 BOTTLETABLET68
71335-0545-2Acetaminophen and Codeine20 in 1 BOTTLETABLET208
71335-0545-3Acetaminophen and Codeine30 in 1 BOTTLETABLET308
71335-0545-4Acetaminophen and Codeine84 in 1 BOTTLETABLET848
71335-0545-5Acetaminophen and Codeine15 in 1 BOTTLETABLET158
71335-0545-6Acetaminophen and Codeine120 in 1 BOTTLETABLET1208
71335-0545-7Acetaminophen and Codeine100 in 1 BOTTLETABLET1008
71335-0545-8Acetaminophen and Codeine60 in 1 BOTTLETABLET608
71335-0545-9Acetaminophen and Codeine90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0545-0EA - Each71335-05456d076c73-e589-41d7-abaa-7fa70df1071212018-03-08
71335-0545-1EA - Each71335-054598bfd1cd-a371-451e-82b5-64892dbb807b12018-03-08
71335-0545-2EA - Each71335-0545509d386f-eee6-4007-b977-8255d84a3baa12018-03-08
71335-0545-3EA - Each71335-05458a121f88-429e-4f2f-bb0a-40958b18fd9512018-03-08
71335-0545-4EA - Each71335-0545b24d0731-cf4f-462b-a064-a97c0e9a60d312018-03-08
71335-0545-5EA - Each71335-05453d47e69a-605c-4991-8836-96750924ecc412018-03-08
71335-0545-6EA - Each71335-05457106ae44-43f7-4d68-8826-fb086a6b97d012018-03-08
71335-0545-7EA - Each71335-0545a803d628-ea68-4054-a130-93fc76f9152f12018-03-08
71335-0545-8EA - Each71335-0545662467b8-33da-4686-bff4-8ff64368606912018-03-08
71335-0545-9EA - Each71335-05457485a804-6a94-43b5-ba6e-c031d8bf5af412018-03-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN7d940b9c-7406-4182-9052-c6a5806337a08
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD7d940b9c-7406-4182-9052-c6a5806337a08
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY7d940b9c-7406-4182-9052-c6a5806337a08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0545-07133505450040 TABLET in 1 BOTTLE (71335-0545-0) 40 tablet2018-05-110000-00-00NoNoCurrent
71335-0545-1713350545016 TABLET in 1 BOTTLE (71335-0545-1) 6 tablet2018-05-010000-00-00NoNoCurrent
71335-0545-27133505450220 TABLET in 1 BOTTLE (71335-0545-2) 20 tablet2018-05-010000-00-00NoNoCurrent
71335-0545-37133505450330 TABLET in 1 BOTTLE (71335-0545-3) 30 tablet2018-05-110000-00-00NoNoCurrent
71335-0545-47133505450484 TABLET in 1 BOTTLE (71335-0545-4) 84 tablet2018-05-110000-00-00NoNoCurrent
71335-0545-57133505450515 TABLET in 1 BOTTLE (71335-0545-5) 15 tablet2018-05-110000-00-00NoNoCurrent
71335-0545-671335054506120 TABLET in 1 BOTTLE (71335-0545-6) 120 tablet2018-05-110000-00-00NoNoCurrent
71335-0545-771335054507100 TABLET in 1 BOTTLE (71335-0545-7) 100 tablet2018-05-110000-00-00NoNoCurrent
71335-0545-87133505450860 TABLET in 1 BOTTLE (71335-0545-8) 60 tablet2018-05-110000-00-00NoNoCurrent
71335-0545-97133505450990 TABLET in 1 BOTTLE (71335-0545-9) 90 tablet2018-05-110000-00-00NoNoCurrent