Hydrocodone Bitartrate and Acetaminophen

Product NDC
55700-781
11-digit product format
557000781
Labeler code
55700
Product ID
55700-781_193b0971-d1ac-425e-b234-d4c425742361
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA211487
Marketing category
ANDA
Marketing start
2019-07-26
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
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-781-012025-01-10C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-102025-01-10C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-212025-01-10C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-302025-01-10C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-402025-01-10C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-602025-01-10C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-902025-01-10C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-012023-01-30C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-102023-01-30C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-212023-01-30C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-302023-01-30C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-402023-01-30C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-602023-01-30C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781
55700-781-902023-01-30C16284748780-1f386c649-f098-0266-e053-dadaa90a7c1ad68de0b1-9437-447c-b2bb-a028b1109781

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-781-01EA - Each55700-781a1a9a633-c07c-40bb-ad5d-bff99a4691b112019-09-05
55700-781-21EA - Each55700-7819a1bad39-0758-49f5-8c0e-bd5afca8571712021-02-05
55700-781-30EA - Each55700-781af378d59-a36c-43be-b4b7-ab50df76436f12020-05-08
55700-781-40EA - Each55700-7810521f58d-7e89-4c83-91f7-5c027a7109c912019-10-07
55700-781-60EA - Each55700-7816511b230-3645-4c8b-a128-9a3be9970e9e12019-09-05
55700-781-90EA - Each55700-7812a7bf0f0-829e-4062-afe9-68d8ee20a47412019-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-781-0155700078101120 TABLET in 1 BOTTLE (55700-781-01) 120 tablet2019-07-260000-00-00NoNoCurrent
55700-781-105570007811030 TABLET in 1 BOTTLE (55700-781-10) 30 tablet2019-07-260000-00-00NoNoCurrent
55700-781-215570007812121 TABLET in 1 BOTTLE (55700-781-21) 21 tablet2021-01-070000-00-00NoNoCurrent
55700-781-305570007813030 TABLET in 1 BOTTLE (55700-781-30) 30 tablet2019-07-260000-00-00NoNoCurrent
55700-781-405570007814040 TABLET in 1 BOTTLE (55700-781-40) 40 tablet2019-08-160000-00-00NoNoCurrent
55700-781-605570007816060 TABLET in 1 BOTTLE (55700-781-60) 60 tablet2019-07-260000-00-00NoNoCurrent
55700-781-905570007819090 TABLET in 1 BOTTLE (55700-781-90) 90 tablet2019-07-260000-00-00NoNoCurrent