Naproxen Sodium

Product NDC
63629-3638
11-digit product format
636293638
Labeler code
63629
Product ID
63629-3638_8dbc4051-330c-4c87-a7a1-b9aa12d7c1c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078314
Marketing category
ANDA
Marketing start
2007-08-01
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
275 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3638-1EA - Each63629-3638da40fa2a-ba2c-49d2-8d99-e6054da0fce812012-07-24
63629-3638-2EA - Each63629-36380d519c6c-0abd-48dc-91e3-4f04c0dfefa412012-07-24
63629-3638-3EA - Each63629-363803698d5b-4949-4cf3-949d-81661613f98112012-07-24
63629-3638-4EA - Each63629-36387f8bed80-32b5-406b-8439-3a84217ae02012012-07-24
63629-3638-5EA - Each63629-3638618c0718-b9b7-4d20-8833-764ed36d438a12012-07-24
63629-3638-6EA - Each63629-36386cfca1bd-e969-4489-9e86-19941e442bc712012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3638-16362936380160 TABLET in 1 BOTTLE (63629-3638-1) 60 tablet2018-06-010000-00-00NoNoCurrent
63629-3638-26362936380290 TABLET in 1 BOTTLE (63629-3638-2) 90 tablet2018-06-010000-00-00NoNoCurrent
63629-3638-36362936380342 TABLET in 1 BOTTLE (63629-3638-3) 42 tablet2018-06-010000-00-00NoNoCurrent
63629-3638-46362936380420 TABLET in 1 BOTTLE (63629-3638-4) 20 tablet2018-06-010000-00-00NoNoCurrent
63629-3638-563629363805120 TABLET in 1 BOTTLE (63629-3638-5) 120 tablet2018-06-010000-00-00NoNoCurrent
63629-3638-66362936380630 TABLET in 1 BOTTLE (63629-3638-6) 30 tablet2018-06-010000-00-00NoNoCurrent