FDA.reportPublic FDA data

Milnacipran Hydrochloride

Product NDC
68462-763
11-digit product format
684620763
Labeler code
68462
Product ID
68462-763_97a7eb14-fa99-40e4-91c2-be5b34f5e203
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
milnacipran hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
NDA022256
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2026-03-19
Substance
MILNACIPRAN HYDROCHLORIDE
Active strength
12.5 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Milnacipran Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILNACIPRAN HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRNZ43O5WW5
Rxcui833135, 833141, 833144, 833147

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7a197179-317f-1516-8da2-c7f3df29602aProduct name420250423

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-763-60Milnacipran Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-763-60EA - Each68462-76387393474-d6a3-4b78-9240-2537812f6c0312026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833135milnacipran HCl 100 MG Oral TabletPSNb66b1850-0d2a-41d6-b0ad-c676166394c74
833141milnacipran HCl 12.5 MG Oral TabletPSNb66b1850-0d2a-41d6-b0ad-c676166394c74
833147milnacipran HCl 25 MG Oral TabletPSNb66b1850-0d2a-41d6-b0ad-c676166394c74
833144milnacipran HCl 50 MG Oral TabletPSNb66b1850-0d2a-41d6-b0ad-c676166394c74
833135milnacipran hydrochloride 100 MG Oral TabletSCDb66b1850-0d2a-41d6-b0ad-c676166394c74
833141milnacipran hydrochloride 12.5 MG Oral TabletSCDb66b1850-0d2a-41d6-b0ad-c676166394c74
833147milnacipran hydrochloride 25 MG Oral TabletSCDb66b1850-0d2a-41d6-b0ad-c676166394c74
833144milnacipran hydrochloride 50 MG Oral TabletSCDb66b1850-0d2a-41d6-b0ad-c676166394c74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68462-763-606846207636060 TABLET, FILM COATED in 1 BOTTLE (68462-763-60) 2026-03-19NoNoCurrent