Diclofenac Sodium

Product NDC
50383-272
11-digit product format
503830272
Labeler code
50383
Product ID
50383-272_8be4a907-f0b3-44da-add4-8305ffff090b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Hi-Tech Pharmacal Co., Inc.
Application
ANDA209484
Marketing category
ANDA
Marketing start
2018-11-30
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],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
50383-272-01GM - Gram50383-272df88827a-1e9c-4cac-b624-d19fc8ad9cdf12019-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-272-01503830272011 TUBE in 1 CARTON (50383-272-01) > 100 g in 1 TUBE1 tube2018-11-300000-00-00NoNoCurrent
50383-272-13503830272133 TUBE in 1 CARTON (50383-272-13) > 100 g in 1 TUBE3 tube2018-11-300000-00-00NoNoCurrent
50383-272-65503830272655 TUBE in 1 CARTON (50383-272-65) > 100 g in 1 TUBE5 tube2018-11-300000-00-00NoNoCurrent