FDA.reportPublic FDA data

MILNACIPRAN HYDROCHLORIDE

Product NDC
31722-880
11-digit product format
317220880
Labeler code
31722
Product ID
31722-880_4cbf720f-9cdf-7cfe-e063-6394a90a6d84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MILNACIPRAN HYDROCHLORIDE
Dosage form
KIT
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA205147
Marketing category
ANDA
Marketing start
2026-03-19
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

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
31722-880-31MILNACIPRAN HYDROCHLORIDE1 in 1 BLISTER PACKKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-880-31EA - Each31722-880330d7fff-978c-4bd3-9300-1d50b139da3212026-04-20

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
31722-880-31317220880311 KIT in 1 BLISTER PACK (31722-880-31) 1 kit2026-03-19NoNoCurrent