HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
42549-514
11-digit product format
425490514
Labeler code
42549
Product ID
42549-514_fe5ba386-ea2e-4884-9ce7-f00f71d4c101
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
STAT Rx USA LLC
Application
ANDA040400
Marketing category
ANDA
Marketing start
2010-04-22
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42549-514-02HYDROCODONE BITARTRATE AND ACETAMINOPHEN112 in 1 BOTTLETABLET1125
42549-514-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN140 in 1 BOTTLETABLET1405
42549-514-12HYDROCODONE BITARTRATE AND ACETAMINOPHEN120 in 1 BOTTLETABLET1205
42549-514-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN28 in 1 BOTTLETABLET285
42549-514-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET305
42549-514-40HYDROCODONE BITARTRATE AND ACETAMINOPHEN40 in 1 BOTTLETABLET405
42549-514-56HYDROCODONE BITARTRATE AND ACETAMINOPHEN56 in 1 BOTTLETABLET565
42549-514-60HYDROCODONE BITARTRATE AND ACETAMINOPHEN60 in 1 BOTTLETABLET605
42549-514-84HYDROCODONE BITARTRATE AND ACETAMINOPHEN84 in 1 BOTTLETABLET845
42549-514-90HYDROCODONE BITARTRATE AND ACETAMINOPHEN90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42549-514-02EA - Each42549-5141eb67c72-7e71-4767-a4be-ee30c42dac1712012-07-24
42549-514-04EA - Each42549-514f35e08cb-e4c7-4774-8986-bb2f04b87fd912012-07-24
42549-514-12EA - Each42549-514f22cb15f-40bb-49fb-9b3b-f5be911314a612012-07-24
42549-514-28EA - Each42549-5142c6c067e-1a15-461c-ab4d-ef5de8a74dae12012-07-24
42549-514-30EA - Each42549-5147826b7f6-a62d-4389-a870-27c9eb4df3cb12012-07-24
42549-514-40EA - Each42549-5145e1facee-1557-47a7-892e-986197b0266612012-07-24
42549-514-60EA - Each42549-514fa766701-24e2-4f3f-9042-a32e75bd801012012-07-24
42549-514-90EA - Each42549-514a3e75827-b3d5-47b6-a746-20b680435c4112012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42549-514HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]5Legacy NDC, 10 package rows20120202_c8be6c8d-7c55-459b-bc16-7651c2fd6e27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNc8be6c8d-7c55-459b-bc16-7651c2fd6e275
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNc8be6c8d-7c55-459b-bc16-7651c2fd6e275
856903HYDROcodone bitartrate 5 MG / acetaminophen 500 MG Oral TabletPSNc8be6c8d-7c55-459b-bc16-7651c2fd6e275
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNc8be6c8d-7c55-459b-bc16-7651c2fd6e275
857118HYDROcodone bitartrate 7.5 MG / acetaminophen 500 MG Oral TabletPSNc8be6c8d-7c55-459b-bc16-7651c2fd6e275
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDc8be6c8d-7c55-459b-bc16-7651c2fd6e275
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDc8be6c8d-7c55-459b-bc16-7651c2fd6e275
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDc8be6c8d-7c55-459b-bc16-7651c2fd6e275
856903acetaminophen 500 MG / hydrocodone bitartrate 5 MG Oral TabletSCDc8be6c8d-7c55-459b-bc16-7651c2fd6e275
857118acetaminophen 500 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDc8be6c8d-7c55-459b-bc16-7651c2fd6e275
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYc8be6c8d-7c55-459b-bc16-7651c2fd6e275
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYc8be6c8d-7c55-459b-bc16-7651c2fd6e275
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYc8be6c8d-7c55-459b-bc16-7651c2fd6e275
856903APAP 500 MG / hydrocodone bitartrate 5 MG Oral TabletSYc8be6c8d-7c55-459b-bc16-7651c2fd6e275
857118APAP 500 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYc8be6c8d-7c55-459b-bc16-7651c2fd6e275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42549-514-0242549051402112 in 1 BOTTLEHistorical
42549-514-0442549051404140 in 1 BOTTLEHistorical
42549-514-1242549051412120 in 1 BOTTLEHistorical
42549-514-284254905142828 in 1 BOTTLEHistorical
42549-514-304254905143030 in 1 BOTTLEHistorical
42549-514-404254905144040 in 1 BOTTLEHistorical
42549-514-564254905145656 in 1 BOTTLEHistorical
42549-514-604254905146060 in 1 BOTTLEHistorical
42549-514-844254905148484 in 1 BOTTLEHistorical
42549-514-904254905149090 in 1 BOTTLEHistorical