Hydrocodone Bitartrate and Acetaminophen

Product NDC
55700-603
11-digit product format
557000603
Labeler code
55700
Product ID
55700-603_c8fd403e-f036-4588-b0b9-2c5246f2ed46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA209037
Marketing category
ANDA
Marketing start
2018-04-13
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
8 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-603-012025-01-09C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-152025-01-09C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-242025-01-09C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-302025-01-09C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-562025-01-09C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-602025-01-09C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-902025-01-09C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-012023-01-30C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-152023-01-30C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-242023-01-30C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-302023-01-30C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-562023-01-30C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-602023-01-30C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6
55700-603-902023-01-30C16284748780-1f386c64a-297b-0266-e053-dadaa90a7c1a3c9116b4-f14a-43aa-9b13-823f465124f6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-603-01EA - Each55700-60328b4f7af-3736-4ca1-b7f8-a110856d457012018-09-05
55700-603-15EA - Each55700-6033552fe53-9d85-48c4-8577-8ba6cd7a56ca12018-05-09
55700-603-24EA - Each55700-603a76fb3b4-c622-4061-9c3b-5c933234248b12018-10-11
55700-603-30EA - Each55700-603a787fc89-947e-4dcb-9a88-5454744d2e4612018-05-09
55700-603-56EA - Each55700-6037ddd8dcd-7a31-4fe5-958d-a0ffbe616df112018-09-05
55700-603-60EA - Each55700-6035b03a26d-4027-431e-a233-cf1ce87a456812018-05-09
55700-603-90EA - Each55700-603cdb726be-9399-4906-b549-a3b67189302c12018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-603-0155700060301120 TABLET in 1 BOTTLE (55700-603-01) 120 tablet2018-08-170000-00-00NoNoCurrent
55700-603-155570006031515 TABLET in 1 BOTTLE (55700-603-15) 15 tablet2018-04-130000-00-00NoNoCurrent
55700-603-245570006032424 TABLET in 1 BOTTLE (55700-603-24) 24 tablet2018-07-130000-00-00NoNoCurrent
55700-603-305570006033030 TABLET in 1 BOTTLE (55700-603-30) 30 tablet2018-04-130000-00-00NoNoCurrent
55700-603-565570006035656 TABLET in 1 BOTTLE (55700-603-56) 56 tablet2018-08-100000-00-00NoNoCurrent
55700-603-605570006036060 TABLET in 1 BOTTLE (55700-603-60) 60 tablet2018-04-130000-00-00NoNoCurrent
55700-603-905570006039090 TABLET in 1 BOTTLE (55700-603-90) 90 tablet2018-04-130000-00-00NoNoCurrent