TOLMETIN SODIUM

Product NDC
16571-825
11-digit product format
165710825
Labeler code
16571
Product ID
16571-825_ff84bf16-f778-489c-9cb0-c6df96b5b56d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolmetin sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA074473
Marketing category
ANDA
Marketing start
2023-04-11
Marketing end
2026-05-31
Substance
TOLMETIN SODIUM
Active strength
600 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ad3a5dc6-863f-442d-2886-f8a057d6cb13Product name120140508
e10d0ded-5358-1a18-d5a9-92245cfbbbf9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-825-09TOLMETIN SODIUM90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-825-09EA - Each16571-82592a1c232-3a9c-49a0-ba6c-140910de622912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-825TOLMETIN SODIUM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]4Current NDC, 1 package rows20241211_fa4096f0-0d22-4421-b4ca-6b1d7f078bd3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-825-091657108250990 TABLET, FILM COATED in 1 BOTTLE (16571-825-09) 2023-04-112026-05-31NoNoHistorical