Naproxen

Product NDC
71297-200
11-digit product format
712970200
Labeler code
71297
Product ID
71297-200_b61f4f8a-87e2-3fa6-e053-2995a90a0b2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Allegis Holdings, LLC
Application
NDA018965
Marketing category
NDA
Marketing start
2019-11-05
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
125 mg/5mL
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71297-200-16ML - Milliliter71297-20051e9f6b3-c0e9-49cc-b3fe-d7960bdb89d812019-12-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71297-200-1671297020016473 mL in 1 BOTTLE (71297-200-16) 473 ml2019-11-050000-00-00NoNoCurrent