Tolmetin Sodium

Product NDC
16571-826
11-digit product format
165710826
Labeler code
16571
Product ID
16571-826_a6175635-172e-4b9e-8388-b60c2aa117a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolmetin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA073393
Marketing category
ANDA
Marketing start
2023-06-30
Marketing end
2026-05-31
Substance
TOLMETIN SODIUM
Active strength
400 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
16571-826-09Tolmetin Sodium90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-826-09EA - Each16571-82634578a17-4fa7-49b7-89c2-4ede5cdc333612023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-826TOLMETIN SODIUM CAPSULE [RISING PHARMA HOLDINGS, INC.]4Current NDC, 1 package rows20241211_740a0f37-aa95-4558-b415-be516b8c40a3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-826-091657108260990 CAPSULE in 1 BOTTLE (16571-826-09) 90 capsule2023-06-302026-05-31NoNoHistorical