FDA.reportPublic FDA data

MILNACIPRAN HYDROCHLORIDE

Product NDC
31722-846
11-digit product format
317220846
Labeler code
31722
Product ID
31722-846_4cbf720f-9cdf-7cfe-e063-6394a90a6d84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MILNACIPRAN HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA205147
Marketing category
ANDA
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, 833150

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7a197179-317f-1516-8da2-c7f3df29602aProduct name420250423
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-846-32MILNACIPRAN HYDROCHLORIDE10 in 1 CARTONTABLET, FILM COATED101
31722-846-32MILNACIPRAN HYDROCHLORIDE10 in 1 BLISTER PACKTABLET, FILM COATED101
31722-846-60MILNACIPRAN HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-846-60EA - Each31722-846bae3e954-3228-4df1-abbc-8fd1b8f950df12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833150{5 (milnacipran hydrochloride 12.5 MG Oral Tablet) / 8 (milnacipran hydrochloride 25 MG Oral Tablet) / 42 (milnacipran hydrochloride 50 MG Oral Tablet) } PackGPCK99efa59a-8458-4e04-8cb1-20abfc1792281
833135milnacipran HCl 100 MG Oral TabletPSN99efa59a-8458-4e04-8cb1-20abfc1792281
833141milnacipran HCl 12.5 MG Oral TabletPSN99efa59a-8458-4e04-8cb1-20abfc1792281
833150milnacipran HCl 12.5 MG Oral Tablet (5) / milnacipran HCl 25 MG Oral Tablet (8) / milnacipran HCl 50 MG Oral Tablet (42) PackPSN99efa59a-8458-4e04-8cb1-20abfc1792281
833147milnacipran HCl 25 MG Oral TabletPSN99efa59a-8458-4e04-8cb1-20abfc1792281
833144milnacipran HCl 50 MG Oral TabletPSN99efa59a-8458-4e04-8cb1-20abfc1792281
833135milnacipran hydrochloride 100 MG Oral TabletSCD99efa59a-8458-4e04-8cb1-20abfc1792281
833141milnacipran hydrochloride 12.5 MG Oral TabletSCD99efa59a-8458-4e04-8cb1-20abfc1792281
833147milnacipran hydrochloride 25 MG Oral TabletSCD99efa59a-8458-4e04-8cb1-20abfc1792281
833144milnacipran hydrochloride 50 MG Oral TabletSCD99efa59a-8458-4e04-8cb1-20abfc1792281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-846-323172208463210 BLISTER PACK in 1 CARTON (31722-846-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2026-03-19NoNoCurrent
31722-846-603172208466060 TABLET, FILM COATED in 1 BOTTLE (31722-846-60) 2026-03-19NoNoCurrent