FDA.reportPublic FDA data

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
72189-348
11-digit product format
721890348
Labeler code
72189
Product ID
72189-348_2eacd5a8-4f00-9d9b-e063-6394a90a0f74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
DirectRx
Application
ANDA211487
Marketing category
ANDA
Marketing start
2022-04-26
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, NO70W886KK
Rxcui856999

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
72189-348-20HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BOTTLETABLET208
72189-348-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET308
72189-348-60HYDROCODONE BITARTRATE AND ACETAMINOPHEN60 in 1 BOTTLETABLET608
72189-348-72HYDROCODONE BITARTRATE AND ACETAMINOPHEN120 in 1 BOTTLETABLET1208
72189-348-90HYDROCODONE BITARTRATE AND ACETAMINOPHEN90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-348-20EA - Each72189-348a7487ef2-9269-4a3e-962b-6623c71a291b12025-03-04
72189-348-30EA - Each72189-3480a512b60-6acf-416f-978f-fe9747fe11f912022-09-12
72189-348-60EA - Each72189-348f4e72f58-a069-45dc-a06d-4337924316fd12022-07-06
72189-348-72EA - Each72189-3486b690e58-315d-4057-b42b-98cd3729fd0e12023-06-06
72189-348-90EA - Each72189-3485b71b7d3-ddad-418f-8cb6-32efff6d08da12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-348HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DIRECTRX]8Current NDC, Legacy NDC, 5 package rows20250224_dd934235-3b2a-51ca-e053-2995a90a0016.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNdd934235-3b2a-51ca-e053-2995a90a00168
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDdd934235-3b2a-51ca-e053-2995a90a00168
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYdd934235-3b2a-51ca-e053-2995a90a00168

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-348-207218903482020 TABLET in 1 BOTTLE (72189-348-20) 20 tablet2022-04-26NoNoCurrent
72189-348-307218903483030 TABLET in 1 BOTTLE (72189-348-30) 30 tablet2022-04-260000-00-00NoNoCurrent
72189-348-607218903486060 TABLET in 1 BOTTLE (72189-348-60) 60 tablet2022-04-260000-00-00NoNoCurrent
72189-348-7272189034872120 TABLET in 1 BOTTLE (72189-348-72) 120 tablet2022-04-260000-00-00NoNoCurrent
72189-348-907218903489090 TABLET in 1 BOTTLE (72189-348-90) 90 tablet2022-04-260000-00-00NoNoCurrent