Hydrocodone Bitartrate and Acetaminophen

Product NDC
55700-771
11-digit product format
557000771
Labeler code
55700
Product ID
55700-771_6d061568-5b89-4fdc-a7ca-bf40f89ad8db
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
2019-06-28
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
5 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
55700-771-012025-01-10C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-052025-01-10C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-122025-01-10C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-142025-01-10C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-152025-01-10C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-212025-01-10C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-302025-01-10C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-402025-01-10C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-602025-01-10C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-902025-01-10C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-012023-01-30C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-052023-01-30C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-122023-01-30C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-142023-01-30C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-152023-01-30C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-212023-01-30C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-302023-01-30C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-402023-01-30C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-602023-01-30C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc
55700-771-902023-01-30C16284748780-1f386c64a-2659-0266-e053-dadaa90a7c1a8cdfc522-1b61-41a3-86cc-5cbde20df6bc

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-771-01EA - Each55700-771341621b2-1888-4c72-9c76-c01de868f66212019-08-06
55700-771-05EA - Each55700-77120706bee-52cd-4cd4-883c-ab4d0126c6d012020-01-03
55700-771-12EA - Each55700-77121678e69-6fb8-4615-8ea7-295a043fb5f712019-08-06
55700-771-14EA - Each55700-77154d2d890-3dc9-4fe9-bdd9-e30ca6b8318f12019-08-06
55700-771-15EA - Each55700-771a737f693-9359-4057-986a-b0033735904b12019-08-06
55700-771-21EA - Each55700-771dec9af75-7b1b-4daa-86a2-23f741efe0a912020-01-03
55700-771-30EA - Each55700-77188695401-6517-4a36-9123-52f02c887a8f12019-08-06
55700-771-40EA - Each55700-7712b7eccdf-efdd-451e-bbaf-f0ece1e866b712019-08-06
55700-771-60EA - Each55700-7718739760b-e0ad-494f-a2b0-06d6fd70cdb112019-08-06
55700-771-90EA - Each55700-7712c26a1b9-47d8-4c51-8a4e-0dec1f6fb33c12019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-771-0155700077101120 TABLET in 1 BOTTLE (55700-771-01) 120 tablet2019-06-280000-00-00NoNoCurrent
55700-771-05557000771055 TABLET in 1 BOTTLE (55700-771-05) 5 tablet2019-11-190000-00-00NoNoCurrent
55700-771-125570007711212 TABLET in 1 BOTTLE (55700-771-12) 12 tablet2019-06-280000-00-00NoNoCurrent
55700-771-145570007711414 TABLET in 1 BOTTLE (55700-771-14) 14 tablet2019-06-280000-00-00NoNoCurrent
55700-771-155570007711515 TABLET in 1 BOTTLE (55700-771-15) 15 tablet2019-06-280000-00-00NoNoCurrent
55700-771-215570007712121 TABLET in 1 BOTTLE (55700-771-21) 21 tablet2019-06-280000-00-00NoNoCurrent
55700-771-305570007713030 TABLET in 1 BOTTLE (55700-771-30) 30 tablet2019-06-280000-00-00NoNoCurrent
55700-771-405570007714040 TABLET in 1 BOTTLE (55700-771-40) 40 tablet2019-06-280000-00-00NoNoCurrent
55700-771-605570007716060 TABLET in 1 BOTTLE (55700-771-60) 60 tablet2019-06-280000-00-00NoNoCurrent
55700-771-905570007719090 TABLET in 1 BOTTLE (55700-771-90) 90 tablet2019-06-280000-00-00NoNoCurrent