FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
50268-400
11-digit product format
502680400
Labeler code
50268
Product ID
50268-400_47e5550b-f34a-dda4-e063-6294a90affee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA040746
Marketing category
ANDA
Marketing start
2016-10-28
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 7.5 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 BITARTRATE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, NO70W886KK
Rxcui857005

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
50268-400-11Hydrocodone Bitartrate and Acetaminophen1 in 1 BLISTER PACKTABLET16
50268-400-15Hydrocodone Bitartrate and Acetaminophen50 in 1 BOXTABLET506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-400-11EA - Each50268-400b3e96b2c-b1d6-46bb-b7d5-928fe902871812016-12-07
50268-400-15EA - Each50268-40096ab2cb1-7e29-4ca4-a7ad-ff7f8a1063f912016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-400HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK]5Current NDC, Legacy NDC, 2 package rows20240110_678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc36
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc36
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-400-11502680400111 in 1 BLISTER PACKHistorical
50268-400-155026804001550 BLISTER PACK in 1 BOX (50268-400-15) / 1 TABLET in 1 BLISTER PACK (50268-400-11) 50 blister pack2016-10-280000-00-00NoNoCurrent