FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
53217-265
11-digit product format
532170265
Labeler code
53217
Product ID
53217-265_91bb8d23-6843-49f8-9c83-737cb591e4d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA201013
Marketing category
ANDA
Marketing start
2016-11-30
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
2019-12-31
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
53217-265-122020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP
53217-265-152020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP
53217-265-202020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP
53217-265-242020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP
53217-265-302020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP
53217-265-602020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP
53217-265-902020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-265-12Hydrocodone Bitartrate and Acetaminophen12 in 1 BOTTLETABLET124
53217-265-15Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET154
53217-265-20Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET204
53217-265-24Hydrocodone Bitartrate and Acetaminophen24 in 1 BOTTLETABLET244
53217-265-30Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET304
53217-265-60Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET604
53217-265-90Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-265-12EA - Each53217-2655a9a4951-3297-43ee-b8a6-87fdfc5a1f5e12017-05-03
53217-265-15EA - Each53217-26523ba962a-b673-45a7-9d2e-7dcac827141712017-05-03
53217-265-20EA - Each53217-2652ce6a05c-8e63-4ebd-8ad5-c751b9194f5012017-05-03
53217-265-24EA - Each53217-26573421055-68d8-4f4b-ab1e-d493588fad5712017-05-03
53217-265-30EA - Each53217-26514ca83dd-1355-444e-9a12-e2364c2a6ffb12017-05-03
53217-265-60EA - Each53217-265a0b205f3-6801-444c-a46a-b775d9ea406712017-05-03
53217-265-90EA - Each53217-2652a1b7bf7-c4b8-443d-9904-007bdfb1984d12017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-265HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]4Legacy NDC, 7 package rows20170412_d8d44758-d9a9-45dc-854d-8c30a52fa955.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNd8d44758-d9a9-45dc-854d-8c30a52fa9554
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNd8d44758-d9a9-45dc-854d-8c30a52fa9554
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNd8d44758-d9a9-45dc-854d-8c30a52fa9554
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDd8d44758-d9a9-45dc-854d-8c30a52fa9554
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDd8d44758-d9a9-45dc-854d-8c30a52fa9554
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDd8d44758-d9a9-45dc-854d-8c30a52fa9554
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYd8d44758-d9a9-45dc-854d-8c30a52fa9554
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYd8d44758-d9a9-45dc-854d-8c30a52fa9554
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYd8d44758-d9a9-45dc-854d-8c30a52fa9554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-265-125321702651212 in 1 BOTTLEHistorical
53217-265-155321702651515 in 1 BOTTLEHistorical
53217-265-205321702652020 in 1 BOTTLEHistorical
53217-265-245321702652424 in 1 BOTTLEHistorical
53217-265-305321702653030 in 1 BOTTLEHistorical
53217-265-605321702656060 in 1 BOTTLEHistorical
53217-265-905321702659090 in 1 BOTTLEHistorical