FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
40032-351
11-digit product format
400320351
Labeler code
40032
Product ID
40032-351_d207a3f2-17b8-47f0-8b10-a6080abeb477
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA206142
Marketing category
ANDA
Marketing start
2016-11-14
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
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
40032-351-012025-01-30C16284748780-12cef2736-8c8f-d83d-e063-dadaa90ab31fHydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
40032-351-032025-01-30C16284748780-12cef2736-8c8f-d83d-e063-dadaa90ab31fHydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
40032-351-052025-01-30C16284748780-12cef2736-8c8f-d83d-e063-dadaa90ab31fHydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-351-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10010
40032-351-03Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET3010
40032-351-05Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-351HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [NOVEL LABORATORIES, INC.]10Legacy NDC, 3 package rows20191221_dd2c0750-7a04-4e95-b5d1-e84c5de75a13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856980HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral TabletPSNdd2c0750-7a04-4e95-b5d1-e84c5de75a1310
856987HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral TabletPSNdd2c0750-7a04-4e95-b5d1-e84c5de75a1310
856992HYDROcodone bitartrate 7.5 MG / acetaminophen 300 MG Oral TabletPSNdd2c0750-7a04-4e95-b5d1-e84c5de75a1310
856980acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral TabletSCDdd2c0750-7a04-4e95-b5d1-e84c5de75a1310
856987acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral TabletSCDdd2c0750-7a04-4e95-b5d1-e84c5de75a1310
856992acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDdd2c0750-7a04-4e95-b5d1-e84c5de75a1310
856980APAP 300 MG / hydrocodone bitartrate 10 MG Oral TabletSYdd2c0750-7a04-4e95-b5d1-e84c5de75a1310
856987APAP 300 MG / hydrocodone bitartrate 5 MG Oral TabletSYdd2c0750-7a04-4e95-b5d1-e84c5de75a1310
856992APAP 300 MG / Hydrocodone Bitartrate 7.5 MG Oral TabletSYdd2c0750-7a04-4e95-b5d1-e84c5de75a1310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-351-0140032035101100 TABLET in 1 BOTTLE (40032-351-01) 100 tablet2016-11-140000-00-00NoNoCurrent
40032-351-034003203510330 TABLET in 1 BOTTLE (40032-351-03) 30 tablet2016-11-140000-00-00NoNoCurrent
40032-351-0540032035105500 TABLET in 1 BOTTLE (40032-351-05) 500 tablet2016-11-140000-00-00NoNoCurrent