FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
10702-191
11-digit product format
107020191
Labeler code
10702
Product ID
10702-191_4a169a07-a8cd-ada4-e063-6394a90ac7d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA209037
Marketing category
ANDA
Marketing start
2017-06-22
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 10 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
HYDROCODONE BITARTRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNO70W886KK, 362O9ITL9D
Rxcui856980, 856987, 856992, 856999, 857002, 857005

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-191-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10017
10702-191-03Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET3017
10702-191-10Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLETABLET100017
10702-191-50Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-191-01EA - Each10702-191a3ca9db2-3ac5-4493-a31c-aac8f600f57412017-11-06
10702-191-10EA - Each10702-191065f1338-7763-410e-81ca-fb946b25ebd212018-05-09
10702-191-50EA - Each10702-19154dee5e9-d73a-446f-9347-e6a429fc3e7812018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-191HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KVK-TECH, INC.]16Current NDC, Legacy NDC, 4 package rows20240118_f1063950-b302-4898-81c2-b1626c9c16ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856980HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral TabletPSNf1063950-b302-4898-81c2-b1626c9c16ef17
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNf1063950-b302-4898-81c2-b1626c9c16ef17
856987HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral TabletPSNf1063950-b302-4898-81c2-b1626c9c16ef17
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNf1063950-b302-4898-81c2-b1626c9c16ef17
856992HYDROcodone bitartrate 7.5 MG / acetaminophen 300 MG Oral TabletPSNf1063950-b302-4898-81c2-b1626c9c16ef17
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNf1063950-b302-4898-81c2-b1626c9c16ef17
856980acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral TabletSCDf1063950-b302-4898-81c2-b1626c9c16ef17
856987acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral TabletSCDf1063950-b302-4898-81c2-b1626c9c16ef17
856992acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDf1063950-b302-4898-81c2-b1626c9c16ef17
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDf1063950-b302-4898-81c2-b1626c9c16ef17
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDf1063950-b302-4898-81c2-b1626c9c16ef17
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDf1063950-b302-4898-81c2-b1626c9c16ef17
856980APAP 300 MG / hydrocodone bitartrate 10 MG Oral TabletSYf1063950-b302-4898-81c2-b1626c9c16ef17
856987APAP 300 MG / hydrocodone bitartrate 5 MG Oral TabletSYf1063950-b302-4898-81c2-b1626c9c16ef17
856992APAP 300 MG / Hydrocodone Bitartrate 7.5 MG Oral TabletSYf1063950-b302-4898-81c2-b1626c9c16ef17
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYf1063950-b302-4898-81c2-b1626c9c16ef17
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYf1063950-b302-4898-81c2-b1626c9c16ef17
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYf1063950-b302-4898-81c2-b1626c9c16ef17
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN888cb616-3fe4-8356-e053-2a95a90a65e15
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD888cb616-3fe4-8356-e053-2a95a90a65e15
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY888cb616-3fe4-8356-e053-2a95a90a65e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-191-0110702019101100 TABLET in 1 BOTTLE (10702-191-01) 100 tablet2017-06-220000-00-00NoNoCurrent
10702-191-031070201910330 TABLET in 1 BOTTLE (10702-191-03) 30 tablet2017-06-220000-00-00NoNoCurrent
10702-191-10107020191101000 TABLET in 1 BOTTLE (10702-191-10) 1000 tablet2017-06-220000-00-00NoNoCurrent
10702-191-5010702019150500 TABLET in 1 BOTTLE (10702-191-50) 500 tablet2017-06-220000-00-00NoNoCurrent