Diclofenac Sodium

Product NDC
70518-2813
11-digit product format
705182813
Labeler code
70518
Product ID
70518-2813_e38a4aa0-03c1-6cbf-e053-2995a90a1b20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium Topical Gel, 1%,
Dosage form
GEL
Route
TOPICAL
Labeler
REMEDYREPACK INC.
Application
ANDA210986
Marketing category
ANDA
Marketing start
2020-07-13
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2813-02022-02-04C16284748780-1d6a99b39-5f71-a426-e053-dadaa90af4c27f5f61aa-ea92-431a-9087-887909983c18
70518-2813-02022-01-28C16284748780-1d6a99b39-5f71-a426-e053-dadaa90af4c27f5f61aa-ea92-431a-9087-887909983c18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2813-0705182813001 TUBE in 1 CARTON (70518-2813-0) > 100 g in 1 TUBE1 tube2020-07-130000-00-00NoNoCurrent