FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
63629-3798
11-digit product format
636293798
Labeler code
63629
Product ID
63629-3798_4a63f06d-a99b-96d5-c55d-ff03ed82943a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA019892
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-11-23
Marketing end
0000-00-00
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3798-0EA - Each63629-379809ab52b5-48a3-483b-8d39-923357da97de12012-07-24
63629-3798-1EA - Each63629-379838eb19cc-5eb0-41e7-a6f0-c43b7155840212012-07-24
63629-3798-2EA - Each63629-37983c2b531a-3314-4e50-ad76-cba515b2ae0612012-07-24
63629-3798-3EA - Each63629-3798ef66def8-6d33-42c0-9529-569124e2766d12012-07-24
63629-3798-4EA - Each63629-3798efeddf2a-affd-4784-ba43-feb195dddbdf12012-07-24
63629-3798-5EA - Each63629-379834e4192c-47b0-4ce2-9413-d1999946b91012012-07-24
63629-3798-6EA - Each63629-3798caa6ef48-5678-47d6-b07d-1381465ab0a112012-07-24
63629-3798-7EA - Each63629-3798010fcd16-1288-4259-9646-e58c3e3f495412012-07-24
63629-3798-8EA - Each63629-379829a952b2-55df-4af6-ba4e-d3df7344844812012-07-24
63629-3798-9EA - Each63629-379840604bc1-e459-4233-b305-2be8b744a59612012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3798-06362937980090 TABLET in 1 BOTTLE (63629-3798-0) 90 tablet2011-04-290000-00-00NoNoCurrent
63629-3798-16362937980130 TABLET in 1 BOTTLE (63629-3798-1) 30 tablet2011-04-290000-00-00NoNoCurrent
63629-3798-263629379802180 TABLET in 1 BOTTLE (63629-3798-2) 180 tablet2021-12-220000-00-00NoNoCurrent
63629-3798-36362937980315 TABLET in 1 BOTTLE (63629-3798-3) 15 tablet2012-06-040000-00-00NoNoCurrent
63629-3798-46362937980420 TABLET in 1 BOTTLE (63629-3798-4) 20 tablet2017-12-220000-00-00NoNoCurrent
63629-3798-56362937980525 TABLET in 1 BOTTLE (63629-3798-5) 25 tablet2010-06-210000-00-00NoNoCurrent
63629-3798-663629379806100 TABLET in 1 BOTTLE (63629-3798-6) 100 tablet2010-08-120000-00-00NoNoCurrent
63629-3798-76362937980760 TABLET in 1 BOTTLE (63629-3798-7) 60 tablet2010-08-250000-00-00NoNoCurrent
63629-3798-86362937980856 TABLET in 1 BOTTLE (63629-3798-8) 56 tablet2011-02-080000-00-00NoNoCurrent
63629-3798-963629379809140 TABLET in 1 BOTTLE (63629-3798-9) 140 tablet2021-12-220000-00-00NoNoCurrent