Milnacipran HCl

Product NDC: 65162-092
11-digit product format: 651620092
Labeler code: 65162
Product ID: 65162-092_ba8b4064-0e7b-4ace-863f-764584d538cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Milnacipran HCl
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA205081
Marketing category: ANDA
Marketing start: 2014-01-31
Marketing end: 0000-00-00
Substance: MILNACIPRAN HYDROCHLORIDE
Active strength: 25 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65162-092		D	Discontinued by firm		2026-08-10
excluded package	package	65162-092	65162-092-06	D	Discontinued by firm		2026-08-10

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205081-001	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2016-04-22
A205081-002	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2016-04-22
A205081-003	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2016-04-22
A205081-004	MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205081-001	AB
A205081-002	AB
A205081-003	AB
A205081-004	AB

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2016-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2016-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2016-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205081-001	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL		2016-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205081-002	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL		2016-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205081-003	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL		2016-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205081-004	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL		2016-04-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205081-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205081-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205081-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205081-004	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205081-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205081-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205081-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205081-004	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7a197179-317f-1516-8da2-c7f3df29602a	Product name	4	20250423

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-092	MILNACIPRAN HCL TABLET [AMNEAL PHARMACEUTICALS LLC]	15	Legacy NDC	20240805_eaa14195-1b9c-423c-9412-d2fe0857e39d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RNZ43O5WW5	MILNACIPRAN HYDROCHLORIDE	101152-94-7	MILNACIPRAN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-092-06	65162009206	60 TABLET in 1 BOTTLE (65162-092-06)	60 tablet	2014-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Milnacipran HCl	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	16