FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
63629-2947
11-digit product format
636292947
Labeler code
63629
Product ID
63629-2947_b4179232-0eed-4646-af30-80b6abc45a2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040746
Marketing category
ANDA
Marketing start
2010-02-18
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2947-0EA - Each63629-2947fbc90557-7f5a-4093-815d-1891b969655812012-07-24
63629-2947-1EA - Each63629-2947426347d5-c965-4d35-a1b4-27cb277b838912012-07-24
63629-2947-2EA - Each63629-2947b01236a7-5156-408e-88ca-73a4a8b2300f12012-07-24
63629-2947-3EA - Each63629-29479906f8e4-0bb3-46ff-83ad-78bb0acd3da812012-07-24
63629-2947-4EA - Each63629-2947dceb9d7a-af68-48bd-b3f5-ed8f66809ea712012-07-24
63629-2947-5EA - Each63629-2947237749f0-c6b6-4ae6-9567-3f604346b33112012-07-24
63629-2947-6EA - Each63629-2947afa2c925-0c36-48d3-b55d-7c2c87d1014212012-07-24
63629-2947-7EA - Each63629-2947ce268004-0bf6-4e91-b406-7cf167d2f16912012-07-24
63629-2947-8EA - Each63629-2947b6c74997-9165-42e1-bc1c-36ca7464b2a212012-07-24
63629-2947-9EA - Each63629-294766323b32-6134-4357-993d-a6ca6ed2776212012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2947-06362929470056 TABLET in 1 BOTTLE (63629-2947-0) 56 tablet2010-02-180000-00-00NoNoCurrent
63629-2947-16362929470130 TABLET in 1 BOTTLE (63629-2947-1) 30 tablet2010-02-180000-00-00NoNoCurrent
63629-2947-26362929470290 TABLET in 1 BOTTLE (63629-2947-2) 90 tablet2010-02-180000-00-00NoNoCurrent
63629-2947-36362929470320 TABLET in 1 BOTTLE (63629-2947-3) 20 tablet2010-02-180000-00-00NoNoCurrent
63629-2947-463629294704120 TABLET in 1 BOTTLE (63629-2947-4) 120 tablet2010-02-180000-00-00NoNoCurrent
63629-2947-563629294705100 TABLET in 1 BOTTLE (63629-2947-5) 100 tablet2010-02-180000-00-00NoNoCurrent
63629-2947-66362929470660 TABLET in 1 BOTTLE (63629-2947-6) 60 tablet2010-02-180000-00-00NoNoCurrent
63629-2947-76362929470740 TABLET in 1 BOTTLE (63629-2947-7) 40 tablet2010-02-180000-00-00NoNoCurrent
63629-2947-86362929470884 TABLET in 1 BOTTLE (63629-2947-8) 84 tablet2010-02-180000-00-00NoNoCurrent
63629-2947-96362929470945 TABLET in 1 BOTTLE (63629-2947-9) 45 tablet2010-02-180000-00-00NoNoCurrent