FDA.reportPublic FDA data

Hydrocodone Bitartrate

Product NDC
47781-392
11-digit product format
477810392
Labeler code
47781
Product ID
47781-392_271ec71a-ed16-53cb-f7a8-8d10949ec504
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA208269
Marketing category
ANDA
Marketing start
2021-03-03
Substance
HYDROCODONE BITARTRATE
Active strength
20 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNO70W886KK

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
47781-392-60Hydrocodone Bitartrate60 in 1 BOTTLETABLET, EXTENDED RELEASE608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-392HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE [ALVOGEN INC.]5Current NDC, Legacy NDC, 1 package rows20240612_f7b55d14-0980-b680-8ceb-7489ff65455e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595764HYDROcodone bitartrate 100 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595770HYDROcodone bitartrate 120 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595730HYDROcodone bitartrate 20 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595740HYDROcodone bitartrate 30 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595746HYDROcodone bitartrate 40 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595752HYDROcodone bitartrate 60 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595758HYDROcodone bitartrate 80 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595764Abuse-Deterrent 24 HR hydrocodone bitartrate 100 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595770Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595730Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595740Abuse-Deterrent 24 HR hydrocodone bitartrate 30 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595746Abuse-Deterrent 24 HR hydrocodone bitartrate 40 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595752Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595758Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595764hydrocodone bitartrate 100 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8
1595770hydrocodone bitartrate 120 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8
1595730hydrocodone bitartrate 20 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8
1595740hydrocodone bitartrate 30 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8
1595746hydrocodone bitartrate 40 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8
1595752hydrocodone bitartrate 60 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8
1595758hydrocodone bitartrate 80 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-392-604778103926060 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-392-60) 2021-03-030000-00-00NoNoCurrent