Levomilnacipran

Product NDC: 65162-411
Requested package NDC: 65162-411-03
11-digit product format: 651620411
Labeler code: 65162
Product ID: 65162-411_9271952e-b176-4c38-90e8-322c714be99d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levomilnacipran
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA210790
Marketing category: ANDA
Marketing start: 2019-02-04
Marketing end: 0000-00-00
Substance: LEVOMILNACIPRAN HYDROCHLORIDE
Active strength: 20 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	65162-411	65162-411-03	D	Discontinued by firm		2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A210790-001	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04
A210790-002	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04
A210790-003	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04
A210790-004	LEVOMILNACIPRAN HYDROCHLORIDE	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210790-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210790-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210790-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210790-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210790-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210790-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210790-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210790-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210790-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210790-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210790-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210790-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210790-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210790-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210790-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210790-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210790-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210790-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210790-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210790-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210790-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210790-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210790-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210790-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210790-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210790-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210790-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210790-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210790-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210790-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210790-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210790-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210790-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210790-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210790-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210790-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210790-001	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210790-002	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210790-003	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210790-004	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2019-02-04	`5bbf6a4d5a75…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-411	LEVOMILNACIPRAN CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]	7	Legacy NDC	20240719_bcbc5d92-e022-4a0d-ab4d-2b0d7aa68c58.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
371U2ZK31U	LEVOMILNACIPRAN HYDROCHLORIDE	175131-60-9	LEVOMILNACIPRAN HYDROCHLORIDE
UGM0326TXX	LEVOMILNACIPRAN	96847-54-0	Levomilnacipran

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-411-03	65162041103	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-411-03)	2019-02-04	0000-00-00	No	No	Current

Levomilnacipran

NDC auxiliary status#

Orange Book products#

Observed Orange Book product history#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#