FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
50436-0109
11-digit product format
504360109
Labeler code
50436
Product ID
50436-0109_9e97a547-73b1-4035-822e-b1a8d86f4aa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040736
Marketing category
ANDA
Marketing start
2010-01-18
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
50436-0109-12021-01-29C16284748780-1ba0f9c33-0e74-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg CII
50436-0109-22021-01-29C16284748780-1ba0f9c33-0e74-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg CII
50436-0109-42021-01-29C16284748780-1ba0f9c33-0e74-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg CII
50436-0109-52021-01-29C16284748780-1ba0f9c33-0e74-a910-e053-dadaa90a0b85Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg CII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0109-1Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET3010
50436-0109-2Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET6010
50436-0109-4Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET4010
50436-0109-5Hydrocodone Bitartrate and Acetaminophen24 in 1 BOTTLETABLET2410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0109-1EA - Each50436-010977f1a90c-ab67-44c4-bb26-b7bc27041aa912017-07-07
50436-0109-2EA - Each50436-010990c5d27d-0127-4c56-94cc-dc16c32fc2ae12017-07-07
50436-0109-4EA - Each50436-010955957a1f-aa6e-4239-85d2-eec9deadb23712017-07-07
50436-0109-5EA - Each50436-01091b86c0d6-9c46-41a1-9ab4-ec79d238419512018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0109HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]10Legacy NDC, 4 package rows20180807_6b0f991d-557a-4653-bebb-68bd8057bbca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN6b0f991d-557a-4653-bebb-68bd8057bbca10
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD6b0f991d-557a-4653-bebb-68bd8057bbca10
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY6b0f991d-557a-4653-bebb-68bd8057bbca10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0109-15043601090130 in 1 BOTTLEHistorical
50436-0109-25043601090260 in 1 BOTTLEHistorical
50436-0109-45043601090440 in 1 BOTTLEHistorical
50436-0109-55043601090524 in 1 BOTTLEHistorical