FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
71335-1248
11-digit product format
713351248
Labeler code
71335
Product ID
71335-1248_7675f93f-f410-45b6-9fe3-8d5396ba012b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202935
Marketing category
ANDA
Marketing start
2018-10-05
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1248-02024-01-30C16284748780-11030e365-200c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP C-II Rx only
71335-1248-12024-01-30C16284748780-11030e365-200c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP C-II Rx only
71335-1248-22024-01-30C16284748780-11030e365-200c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP C-II Rx only
71335-1248-32024-01-30C16284748780-11030e365-200c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP C-II Rx only
71335-1248-42024-01-30C16284748780-11030e365-200c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP C-II Rx only
71335-1248-52024-01-30C16284748780-11030e365-200c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP C-II Rx only
71335-1248-62024-01-30C16284748780-11030e365-200c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP C-II Rx only
71335-1248-72024-01-30C16284748780-11030e365-200c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP C-II Rx only
71335-1248-82024-01-30C16284748780-11030e365-200c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP C-II Rx only
71335-1248-92024-01-30C16284748780-11030e365-200c-111a-e063-dadaa90a10e2Hydrocodone Bitartrate and Acetaminophen Tablets, USP C-II Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1248-0Hydrocodone Bitartrate and Acetaminophen180 in 1 BOTTLETABLET1802
71335-1248-1Hydrocodone Bitartrate and Acetaminophen84 in 1 BOTTLETABLET842
71335-1248-2Hydrocodone Bitartrate and Acetaminophen8 in 1 BOTTLETABLET82
71335-1248-3Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET202
71335-1248-4Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET302
71335-1248-5Hydrocodone Bitartrate and Acetaminophen45 in 1 BOTTLETABLET452
71335-1248-6Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET602
71335-1248-7Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET902
71335-1248-8Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET1002
71335-1248-9Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1248-4EA - Each71335-12488a52cd67-4020-41a5-9949-f45d742033e512020-09-14
71335-1248-6EA - Each71335-124875ca558f-6377-4ace-9254-e9f357708c9212020-09-14
71335-1248-7EA - Each71335-1248e4d7a3cd-ef8b-4b54-a4b2-36bc75ac8e8812020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1248HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]2Legacy NDC, 10 package rows20220204_7675f93f-f410-45b6-9fe3-8d5396ba012b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN7675f93f-f410-45b6-9fe3-8d5396ba012b2
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD7675f93f-f410-45b6-9fe3-8d5396ba012b2
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY7675f93f-f410-45b6-9fe3-8d5396ba012b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1248-071335124800180 TABLET in 1 BOTTLE (71335-1248-0) 180 tablet2019-06-200000-00-00NoNoCurrent
71335-1248-17133512480184 TABLET in 1 BOTTLE (71335-1248-1) 84 tablet2019-06-200000-00-00NoNoCurrent
71335-1248-2713351248028 TABLET in 1 BOTTLE (71335-1248-2) 8 tablet2019-06-200000-00-00NoNoCurrent
71335-1248-37133512480320 TABLET in 1 BOTTLE (71335-1248-3) 20 tablet2019-06-200000-00-00NoNoCurrent
71335-1248-47133512480430 TABLET in 1 BOTTLE (71335-1248-4) 30 tablet2019-06-200000-00-00NoNoCurrent
71335-1248-57133512480545 TABLET in 1 BOTTLE (71335-1248-5) 45 tablet2019-06-200000-00-00NoNoCurrent
71335-1248-67133512480660 TABLET in 1 BOTTLE (71335-1248-6) 60 tablet2019-06-200000-00-00NoNoCurrent
71335-1248-77133512480790 TABLET in 1 BOTTLE (71335-1248-7) 90 tablet2019-06-200000-00-00NoNoCurrent
71335-1248-871335124808100 TABLET in 1 BOTTLE (71335-1248-8) 100 tablet2019-06-200000-00-00NoNoCurrent
71335-1248-971335124809120 TABLET in 1 BOTTLE (71335-1248-9) 120 tablet2019-06-200000-00-00NoNoCurrent