FDA.reportPublic FDA data

MILNACIPRAN HYDROCHLORIDE

Product NDC
31722-848
11-digit product format
317220848
Labeler code
31722
Product ID
31722-848_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
50 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205147-001MILNACIPRAN HYDROCHLORIDEMILNACIPRAN HYDROCHLORIDE12.5MGTABLET / ORALAB2024-10-03
A205147-002MILNACIPRAN HYDROCHLORIDEMILNACIPRAN HYDROCHLORIDE25MGTABLET / ORALAB2024-10-03
A205147-003MILNACIPRAN HYDROCHLORIDEMILNACIPRAN HYDROCHLORIDE50MGTABLET / ORALAB2024-10-03
A205147-004MILNACIPRAN HYDROCHLORIDEMILNACIPRAN HYDROCHLORIDE100MGTABLET / ORALAB2024-10-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A205147-001AB
A205147-002AB
A205147-003AB
A205147-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205147-001MILNACIPRAN HYDROCHLORIDE12.5MGTABLET / ORAL2024-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205147-002MILNACIPRAN HYDROCHLORIDE25MGTABLET / ORAL2024-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205147-003MILNACIPRAN HYDROCHLORIDE50MGTABLET / ORAL2024-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205147-004MILNACIPRAN HYDROCHLORIDE100MGTABLET / ORAL2024-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205147-001MILNACIPRAN HYDROCHLORIDE12.5MGTABLET / ORAL2024-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205147-002MILNACIPRAN HYDROCHLORIDE25MGTABLET / ORAL2024-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205147-003MILNACIPRAN HYDROCHLORIDE50MGTABLET / ORAL2024-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205147-004MILNACIPRAN HYDROCHLORIDE100MGTABLET / ORAL2024-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A205147-001MILNACIPRAN HYDROCHLORIDE12.5MGTABLET / ORAL2024-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205147-002MILNACIPRAN HYDROCHLORIDE25MGTABLET / ORAL2024-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205147-003MILNACIPRAN HYDROCHLORIDE50MGTABLET / ORAL2024-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205147-004MILNACIPRAN HYDROCHLORIDE100MGTABLET / ORAL2024-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205147-001MILNACIPRAN HYDROCHLORIDE12.5MGTABLET / ORALAB2024-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205147-002MILNACIPRAN HYDROCHLORIDE25MGTABLET / ORALAB2024-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205147-003MILNACIPRAN HYDROCHLORIDE50MGTABLET / ORALAB2024-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205147-004MILNACIPRAN HYDROCHLORIDE100MGTABLET / ORALAB2024-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205147-001MILNACIPRAN HYDROCHLORIDE12.5MGTABLET / ORALAB2024-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205147-002MILNACIPRAN HYDROCHLORIDE25MGTABLET / ORALAB2024-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205147-003MILNACIPRAN HYDROCHLORIDE50MGTABLET / ORALAB2024-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205147-004MILNACIPRAN HYDROCHLORIDE100MGTABLET / ORALAB2024-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205147-001MILNACIPRAN HYDROCHLORIDE12.5MGTABLET / ORALAB2024-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205147-002MILNACIPRAN HYDROCHLORIDE25MGTABLET / ORALAB2024-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205147-003MILNACIPRAN HYDROCHLORIDE50MGTABLET / ORALAB2024-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205147-004MILNACIPRAN HYDROCHLORIDE100MGTABLET / ORALAB2024-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205147-001MILNACIPRAN HYDROCHLORIDE12.5MGTABLET / ORALAB2024-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205147-002MILNACIPRAN HYDROCHLORIDE25MGTABLET / ORALAB2024-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205147-003MILNACIPRAN HYDROCHLORIDE50MGTABLET / ORALAB2024-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205147-004MILNACIPRAN HYDROCHLORIDE100MGTABLET / ORALAB2024-10-032680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205147-001MILNACIPRAN HYDROCHLORIDE12.5MGTABLET / ORALAB2024-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205147-002MILNACIPRAN HYDROCHLORIDE25MGTABLET / ORALAB2024-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205147-003MILNACIPRAN HYDROCHLORIDE50MGTABLET / ORALAB2024-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205147-004MILNACIPRAN HYDROCHLORIDE100MGTABLET / ORALAB2024-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205147-001MILNACIPRAN HYDROCHLORIDE12.5MGTABLET / ORALAB2024-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A205147-002MILNACIPRAN HYDROCHLORIDE25MGTABLET / ORALAB2024-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A205147-003MILNACIPRAN HYDROCHLORIDE50MGTABLET / ORALAB2024-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A205147-004MILNACIPRAN HYDROCHLORIDE100MGTABLET / ORALAB2024-10-03d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205147-001MILNACIPRAN HYDROCHLORIDE12.5MGTABLET / ORALAB2024-10-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205147-002MILNACIPRAN HYDROCHLORIDE25MGTABLET / ORALAB2024-10-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205147-003MILNACIPRAN HYDROCHLORIDE50MGTABLET / ORALAB2024-10-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205147-004MILNACIPRAN HYDROCHLORIDE100MGTABLET / ORALAB2024-10-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205147-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205147-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205147-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205147-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205147-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205147-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205147-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205147-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205147-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205147-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205147-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205147-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205147-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205147-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205147-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205147-004AB12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205147-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205147-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205147-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205147-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205147-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205147-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205147-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205147-004AB1d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205147-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205147-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205147-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205147-004AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
MILNACIPRAN HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILNACIPRAN HYDROCHLORIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RNZ43O5WW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
833135Internal RxNorm lookup
833141Internal RxNorm lookup
833144Internal RxNorm lookup
833147Internal RxNorm lookup
833150Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
99efa59a-8458-4e04-8cb1-20abfc179228Available on FDA.report

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
31722-848-32MILNACIPRAN HYDROCHLORIDE10 in 1 CARTONTABLET, FILM COATED101
31722-848-32MILNACIPRAN HYDROCHLORIDE10 in 1 BLISTER PACKTABLET, FILM COATED101
31722-848-60MILNACIPRAN HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-848-60EA - Each31722-848958c94d5-0812-4fc6-b92a-1041278dff6d12026-04-20

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILNACIPRAN HYDROCHLORIDEMILNACIPRAN HYDROCHLORIDECamber Pharmaceuticals, Inc.99efa59a-8458-4e04-8cb1-20abfc1792282026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205147
application number: ANDA205147
ndc (product): 31722-848

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
31722-848-323172208483210 BLISTER PACK in 1 CARTON (31722-848-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2026-03-19NoNoCurrent
31722-848-603172208486060 TABLET, FILM COATED in 1 BOTTLE (31722-848-60) 2026-03-19NoNoCurrent