Naproxen

Product NDC
49999-049
11-digit product format
499990049
Labeler code
49999
Product ID
49999-049_4fb639f1-a1a0-4112-8a8a-666c138cd15d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA078250
Marketing category
ANDA
Marketing start
2011-11-04
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
375 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
2022-12-31
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
49999-049-01EA - Each49999-04963f87158-f321-43e3-bb10-7edcec1bb69012012-07-24
49999-049-10EA - Each49999-049c2e91351-ca0a-4ccc-b188-c3562d48d1d812012-07-24
49999-049-20EA - Each49999-049061736f2-8492-471a-b144-7878312a825d12012-07-24
49999-049-28EA - Each49999-049a9cd8ccc-d4ca-4ea8-b820-7905ee6f197f12012-07-24
49999-049-30EA - Each49999-04983445006-7dac-40d7-84a0-65b1d3a3b4a412012-07-24
49999-049-60EA - Each49999-0490c17a1b5-858a-46b4-8cfa-83ce8307bb9112012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49999-049-304999900493030 TABLET in 1 BOTTLE, PLASTIC (49999-049-30) 30 tablet2021-04-300000-00-00NoNoCurrent
49999-049-604999900496060 TABLET in 1 BOTTLE, PLASTIC (49999-049-60) 60 tablet2011-11-040000-00-00NoNoCurrent