Tolmetin Sodium

Product NDC
0378-5200
11-digit product format
003785200
Labeler code
0378
Product ID
0378-5200_6dfeb00a-0dc0-446e-9632-a0d2496c53bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolmetin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA073393
Marketing category
ANDA
Marketing start
1993-05-27
Marketing end
0000-00-00
Substance
TOLMETIN SODIUM
Active strength
400 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5200-01EA - Each0378-520042ada09f-582a-4481-99dc-e21a91f50d2412012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-5200-0100378520001100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5200-01) 100 capsule1993-05-270000-00-00NoNoCurrent