Hydrocodone Bitartrate and Ibuprofen

Product NDC
63629-5437
11-digit product format
636295437
Labeler code
63629
Product ID
63629-5437_03512d03-fad7-4ab5-81fc-83ca86faef90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076642
Marketing category
ANDA
Marketing start
2010-02-18
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; IBUPROFEN
Active strength
3 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-5437-02022-02-16C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-12022-02-16C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-22022-02-16C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-32022-02-16C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-42022-02-16C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-52022-02-16C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-62022-02-16C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-72022-02-16C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-82022-02-16C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-92022-02-16C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-02020-01-31C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-12020-01-31C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-22020-01-31C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-32020-01-31C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-42020-01-31C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-52020-01-31C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-62020-01-31C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-72020-01-31C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-82020-01-31C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90
63629-5437-92020-01-31C16284748780-19d75b9cf-e23a-f424-e053-dadaa90a57ce03512d03-fad7-4ab5-81fc-83ca86faef90

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5437-1EA - Each63629-5437dff52a39-d05d-462f-9873-bf9833e104ba12015-10-02
63629-5437-2EA - Each63629-543713d300ae-982b-47c1-84f4-4b473f65f15c12015-10-02
63629-5437-3EA - Each63629-5437dacf8c20-51d8-4ff9-85ce-5cde53610c3c12015-10-02
63629-5437-4EA - Each63629-543774f824db-a0e5-4180-a719-0d80531785d512015-10-02
63629-5437-5EA - Each63629-54371da45767-8221-4780-b24e-c6365a725fdf12015-10-02
63629-5437-6EA - Each63629-54378d4565fd-75fd-4c53-91af-be83da79c72f12015-10-02
63629-5437-7EA - Each63629-543791a77b3a-e289-4601-b206-f0cf01ddd7da12015-10-02
63629-5437-8EA - Each63629-5437f0ffce11-9b5b-4233-b05f-7e0ef4bf0cc812015-10-02
63629-5437-9EA - Each63629-5437d77b7cfc-547c-4a8b-86e3-1b7a19543e2c12015-10-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5437-06362954370015 TABLET in 1 BOTTLE (63629-5437-0) 15 tablet2022-02-080000-00-00NoNoCurrent
63629-5437-163629543701120 TABLET in 1 BOTTLE (63629-5437-1) 120 tablet2014-11-100000-00-00NoNoCurrent
63629-5437-26362954370220 TABLET in 1 BOTTLE (63629-5437-2) 20 tablet2022-02-080000-00-00NoNoCurrent
63629-5437-36362954370328 TABLET in 1 BOTTLE (63629-5437-3) 28 tablet2022-02-080000-00-00NoNoCurrent
63629-5437-46362954370430 TABLET in 1 BOTTLE (63629-5437-4) 30 tablet2014-10-140000-00-00NoNoCurrent
63629-5437-56362954370540 TABLET in 1 BOTTLE (63629-5437-5) 40 tablet2022-02-080000-00-00NoNoCurrent
63629-5437-66362954370645 TABLET in 1 BOTTLE (63629-5437-6) 45 tablet2022-02-080000-00-00NoNoCurrent
63629-5437-76362954370760 TABLET in 1 BOTTLE (63629-5437-7) 60 tablet2014-10-150000-00-00NoNoCurrent
63629-5437-86362954370884 TABLET in 1 BOTTLE (63629-5437-8) 84 tablet2022-02-080000-00-00NoNoCurrent
63629-5437-96362954370990 TABLET in 1 BOTTLE (63629-5437-9) 90 tablet2022-02-080000-00-00NoNoCurrent