Fetzima

Product NDC: 0456-2280
11-digit product format: 004562280
Labeler code: 0456
Product ID: 0456-2280_b4f9c587-d1eb-462b-bad2-ed0ce6d76c57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVOMILNACIPRAN HYDROCHLORIDE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Allergan, Inc.
Application: NDA204168
Marketing category: NDA
Marketing start: 2013-07-25
Substance: LEVOMILNACIPRAN HYDROCHLORIDE
Active strength: 80 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 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	TE codes	RLD / RS	Approval date
N204168-001	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25
N204168-002	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25
N204168-003	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25
N204168-004	FETZIMA	LEVOMILNACIPRAN HYDROCHLORIDE	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204168-001	AB
N204168-002	AB
N204168-003	AB
N204168-004	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204168-001	RE43879	2026-01-11	U-839		2013-08-15
N204168-001	8481598	2031-03-02	U-839		2013-08-15
N204168-001	8865937	2032-05-23		Drug substance, Drug product	2014-11-20
N204168-002	RE43879	2026-01-11	U-839		2013-08-15
N204168-002	8481598	2031-03-02	U-839		2013-08-15
N204168-002	8865937	2032-05-23		Drug substance, Drug product	2014-11-20
N204168-003	RE43879	2026-01-11	U-839		2013-08-15
N204168-003	8481598	2031-03-02	U-839		2013-08-15
N204168-003	8865937	2032-05-23		Drug substance, Drug product	2014-11-20
N204168-004	RE43879	2026-01-11	U-839		2013-08-15
N204168-004	8481598	2031-03-02	U-839		2013-08-15
N204168-004	8865937	2032-05-23		Drug substance, Drug product	2014-11-20

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204168-001	M-304	2026-03-24
N204168-002	M-304	2026-03-24
N204168-003	M-304	2026-03-24
N204168-004	M-304	2026-03-24

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-001	FETZIMA	EQ 20MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-002	FETZIMA	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-003	FETZIMA	EQ 80MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2013-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-004	FETZIMA	EQ 120MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2013-07-25	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N204168-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204168-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204168-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-004	AB	1	`31067a03dcf5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204168-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204168-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204168-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204168-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204168-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204168-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204168-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204168-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204168-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204168-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204168-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204168-004	AB	1	`8869cabd3fbd…`
2023-01-26 05:58 UTC	2023-01	N204168-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N204168-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N204168-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N204168-004	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204168-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204168-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204168-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204168-004	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 516 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204168-001	RE43879	2026-01-11	U-839		2013-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-001	8481598	2031-03-02	U-839		2013-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-001	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-002	RE43879	2026-01-11	U-839		2013-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-002	8481598	2031-03-02	U-839		2013-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-002	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-003	RE43879	2026-01-11	U-839		2013-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-003	8481598	2031-03-02	U-839		2013-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-003	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-004	RE43879	2026-01-11	U-839		2013-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-004	8481598	2031-03-02	U-839		2013-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-004	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204168-001	RE43879	2026-01-11	U-839		2013-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-001	8481598	2031-03-02	U-839		2013-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-001	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-002	RE43879	2026-01-11	U-839		2013-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-002	8481598	2031-03-02	U-839		2013-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-002	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-003	RE43879	2026-01-11	U-839		2013-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-003	8481598	2031-03-02	U-839		2013-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-003	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-004	RE43879	2026-01-11	U-839		2013-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-004	8481598	2031-03-02	U-839		2013-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-004	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204168-001	RE43879	2026-01-11	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-001	8481598	2031-03-02	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-001	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-002	RE43879	2026-01-11	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-002	8481598	2031-03-02	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-002	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-003	RE43879	2026-01-11	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-003	8481598	2031-03-02	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-003	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-004	RE43879	2026-01-11	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-004	8481598	2031-03-02	U-839		2013-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-004	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-001	RE43879	2026-01-11	U-839		2013-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-001	8481598	2031-03-02	U-839		2013-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-001	8865937	2032-05-23		Drug substance, Drug product	2014-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-002	RE43879	2026-01-11	U-839		2013-08-15	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N204168-001	M-304	2026-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-002	M-304	2026-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-003	M-304	2026-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204168-004	M-304	2026-03-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204168-001	M-304	2026-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-002	M-304	2026-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-003	M-304	2026-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204168-004	M-304	2026-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204168-001	M-304	2026-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-002	M-304	2026-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-003	M-304	2026-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204168-004	M-304	2026-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-001	M-304	2026-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-002	M-304	2026-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-003	M-304	2026-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204168-004	M-304	2026-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204168-001	M-304	2026-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-002	M-304	2026-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-003	M-304	2026-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204168-004	M-304	2026-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-001	M-304	2026-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-002	M-304	2026-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-003	M-304	2026-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204168-004	M-304	2026-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-001	M-304	2026-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-002	M-304	2026-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-003	M-304	2026-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204168-004	M-304	2026-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-001	M-304	2026-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-002	M-304	2026-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-003	M-304	2026-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204168-004	M-304	2026-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-001	M-304	2026-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-002	M-304	2026-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-003	M-304	2026-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204168-004	M-304	2026-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-001	M-304	2026-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-002	M-304	2026-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-003	M-304	2026-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204168-004	M-304	2026-03-24	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fetzima
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOMILNACIPRAN HYDROCHLORIDE	80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
371U2ZK31U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1433217	Internal RxNorm lookup
1433223	Internal RxNorm lookup
1433227	Internal RxNorm lookup
1433229	Internal RxNorm lookup
1433233	Internal RxNorm lookup
1433235	Internal RxNorm lookup
1433239	Internal RxNorm lookup
1433241	Internal RxNorm lookup
1433249	Internal RxNorm lookup
1433250	Internal RxNorm lookup
2636817	Internal RxNorm lookup
2636818	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f371258d-91b3-4b6a-ac99-434a1964c3af	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7efbf4fa-913e-470a-89c4-2a84490ad12a	Product name	4	20240320

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0456-2280-30	Fetzima	30 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	30		33
0456-2280-90	Fetzima	90 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	90		33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0456-2280-30	EA - Each	0456-2280	5dab3f85-9315-438d-81b3-6155bbf20845	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOMILNACIPRAN HYDROCHLORIDE	ACTIVE INGREDIENT	371U2ZK31U	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5
levomilnacipran	ACTIVE MOIETY	UGM0326TXX	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5
ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5
povidone	INACTIVE INGREDIENT	FZ989GH94E	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5
shellac	INACTIVE INGREDIENT	46N107B71O	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5
talc	INACTIVE INGREDIENT	7SEV7J4R1U	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0456-2280	FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [ALLERGAN, INC.]	31	Current NDC, Legacy NDC, 2 package rows	20240502_f371258d-91b3-4b6a-ac99-434a1964c3af.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	f371258d-91b3-4b6a-ac99-434a1964c3af	2024-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204168 application number: NDA204168 ndc (product): 0456-2280

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
371U2ZK31U	LEVOMILNACIPRAN HYDROCHLORIDE	175131-60-9	LEVOMILNACIPRAN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1433250	{2 (24 HR levomilnacipran 20 MG Extended Release Oral Capsule [Fetzima]) / 26 (24 HR levomilnacipran 40 MG Extended Release Oral Capsule [Fetzima]) } Pack [Fetzima Pack]	BPCK	f371258d-91b3-4b6a-ac99-434a1964c3af	33
2636818	{2 (24 HR levomilnacipran 20 MG Extended Release Oral Capsule [Fetzima]) / 5 (24 HR levomilnacipran 40 MG Extended Release Oral Capsule [Fetzima]) } Pack [Fetzima Titration Sample Pack]	BPCK	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433249	{2 (24 HR levomilnacipran 20 MG Extended Release Oral Capsule) / 26 (24 HR levomilnacipran 40 MG Extended Release Oral Capsule) } Pack	GPCK	f371258d-91b3-4b6a-ac99-434a1964c3af	33
2636817	{2 (24 HR levomilnacipran 20 MG Extended Release Oral Capsule) / 5 (24 HR levomilnacipran 40 MG Extended Release Oral Capsule) } Pack	GPCK	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433223	Fetzima 120 MG 24HR Extended Release Oral Capsule	PSN	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433229	Fetzima 20 MG 24HR Extended Release Oral Capsule	PSN	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433235	Fetzima 40 MG 24HR Extended Release Oral Capsule	PSN	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433241	Fetzima 80 MG 24HR Extended Release Oral Capsule	PSN	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433250	Fetzima Titration Pack, 20 MG (2), 40 MG (26)	PSN	f371258d-91b3-4b6a-ac99-434a1964c3af	33
2636818	Fetzima Titration Sample Pack, 20 MG (2), 40 MG (5)	PSN	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433217	levomilnacipran 120 MG 24HR Extended Release Oral Capsule	PSN	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433227	levomilnacipran 20 MG 24HR Extended Release Oral Capsule	PSN	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433249	levomilnacipran 20 MG 24HR Extended Release Oral Capsule (2) / levomilnacipran 40 MG 24HR Extended Release Oral Capsule (26) Pack	PSN	f371258d-91b3-4b6a-ac99-434a1964c3af	33
2636817	levomilnacipran 20 MG 24HR Extended Release Oral Capsule (2) / levomilnacipran 40 MG 24HR Extended Release Oral Capsule (5) Pack	PSN	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433233	levomilnacipran 40 MG 24HR Extended Release Oral Capsule	PSN	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433239	levomilnacipran 80 MG 24HR Extended Release Oral Capsule	PSN	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433223	24 HR levomilnacipran 120 MG Extended Release Oral Capsule [Fetzima]	SBD	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433229	24 HR levomilnacipran 20 MG Extended Release Oral Capsule [Fetzima]	SBD	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433235	24 HR levomilnacipran 40 MG Extended Release Oral Capsule [Fetzima]	SBD	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433241	24 HR levomilnacipran 80 MG Extended Release Oral Capsule [Fetzima]	SBD	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433217	24 HR levomilnacipran 120 MG Extended Release Oral Capsule	SCD	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433227	24 HR levomilnacipran 20 MG Extended Release Oral Capsule	SCD	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433233	24 HR levomilnacipran 40 MG Extended Release Oral Capsule	SCD	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433239	24 HR levomilnacipran 80 MG Extended Release Oral Capsule	SCD	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433223	24 HR Fetzima 120 MG Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433229	24 HR Fetzima 20 MG Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433235	24 HR Fetzima 40 MG Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433241	24 HR Fetzima 80 MG Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433223	Fetzima (levomilnacipran 120 MG (as levomilnacipran hydrochloride 137.8 MG)) 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433229	Fetzima (levomilnacipran 20 MG (as levomilnacipran hydrochloride 23 MG)) 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433235	Fetzima (levomilnacipran 40 MG (as levomilnacipran hydrochloride 45.9 MG)) 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433241	Fetzima (levomilnacipran 80 MG (as levomilnacipran hydrochloride 91.8 MG)) 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433223	Fetzima 120 MG 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433229	Fetzima 20 MG 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433235	Fetzima 40 MG 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433241	Fetzima 80 MG 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433250	Fetzima Titration Pack	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
2636818	Fetzima Titration Sample Pack	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433217	levomilnacipran 120 MG (as levomilnacipran hydrochloride 137.8 MG) 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433227	levomilnacipran 20 MG (as levomilnacipran hydrochloride 23 MG) 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433249	levomilnacipran 20 MG 24HR Extended Release Oral Capsule (2) / levomilnacipran 40 MG 24HR Extended Release Oral Capsule (26) Pack (Capsule)	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
2636817	levomilnacipran 20 MG 24HR Extended Release Oral Capsule (2) / levomilnacipran 40 MG 24HR Extended Release Oral Capsule (5) Pack	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433233	levomilnacipran 40 MG (as levomilnacipran hydrochloride 45.9 MG) 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433233	levomilnacipran 40 MG 24HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433239	levomilnacipran 80 MG (as levomilnacipran hydrochloride 91.8 MG) 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33
1433239	levomilnacipran 80 MG 24 HR Extended Release Oral Capsule	SY	f371258d-91b3-4b6a-ac99-434a1964c3af	33

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0456-2280-30	00456228030	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2280-30)	2013-07-25	0000-00-00	No	No	Current
0456-2280-90	00456228090	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2280-90)	2013-07-25	0000-00-00	No	No	Current