Savella

Product NDC: 50436-9993
11-digit product format: 504369993
Labeler code: 50436
Product ID: 50436-9993_fc412246-7fad-449e-870a-39730864ad73
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: milnacipran hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
Application: NDA022256
Marketing category: NDA
Marketing start: 2009-04-17
Marketing end: 0000-00-00
Substance: MILNACIPRAN HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	50436-9993		I	Inactivated by FDA		2026-08-10
excluded package	package	50436-9993	50436-9993-2	I	Inactivated by FDA		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-9993-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-9993-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-9993-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-9993-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-9993-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-9993-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-9993-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-9993-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-9993-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-9993-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-9993-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-9993-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-9993-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-9993-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-9993-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50436-9993-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50436-9993-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50436-9993-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50436-9993-2	`8dfbde2a14a4…`	`c9ff85d89658…`

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	RLD / RS	Approval date
N022256-001	SAVELLA	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14
N022256-002	SAVELLA	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD	2009-01-14
N022256-003	SAVELLA	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14
N022256-004	SAVELLA	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD	2009-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022256-001	AB
N022256-002	AB
N022256-003	AB
N022256-004	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022256-001	7994220	2029-09-19	U-819	2011-09-01
N022256-002	7994220	2029-09-19	U-819
N022256-003	7994220	2029-09-19	U-819
N022256-004	7994220	2029-09-19	U-819

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-001	SAVELLA	12.5MG	TABLET / ORAL		RLD	2009-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-002	SAVELLA	25MG	TABLET / ORAL		RLD	2009-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-003	SAVELLA	50MG	TABLET / ORAL		RLD, RS	2009-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-004	SAVELLA	100MG	TABLET / ORAL		RLD	2009-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022256-001	SAVELLA	12.5MG	TABLET / ORAL		RLD	2009-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022256-002	SAVELLA	25MG	TABLET / ORAL		RLD	2009-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022256-003	SAVELLA	50MG	TABLET / ORAL		RLD, RS	2009-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022256-004	SAVELLA	100MG	TABLET / ORAL		RLD	2009-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-001	SAVELLA	12.5MG	TABLET / ORAL		RLD	2009-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-002	SAVELLA	25MG	TABLET / ORAL		RLD	2009-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-003	SAVELLA	50MG	TABLET / ORAL		RLD, RS	2009-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-004	SAVELLA	100MG	TABLET / ORAL		RLD	2009-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022256-001	SAVELLA	12.5MG	TABLET / ORAL	AB	RLD	2009-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-002	SAVELLA	25MG	TABLET / ORAL	AB	RLD	2009-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-003	SAVELLA	50MG	TABLET / ORAL	AB	RLD, RS	2009-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-004	SAVELLA	100MG	TABLET / ORAL	AB	RLD	2009-01-14	`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	N022256-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-004	AB	1	`011fe1cb6892…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-004	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022256-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-004	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022256-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022256-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022256-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022256-004	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 332 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-002	7994220	2029-09-19	U-819		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-003	7994220	2029-09-19	U-819		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022256-004	7994220	2029-09-19	U-819		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-002	7994220	2029-09-19	U-819		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-003	7994220	2029-09-19	U-819		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022256-004	7994220	2029-09-19	U-819		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022256-002	7994220	2029-09-19	U-819		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022256-003	7994220	2029-09-19	U-819		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022256-004	7994220	2029-09-19	U-819		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-002	7994220	2029-09-19	U-819		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-003	7994220	2029-09-19	U-819		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022256-004	7994220	2029-09-19	U-819		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-002	7994220	2029-09-19	U-819		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-003	7994220	2029-09-19	U-819		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022256-004	7994220	2029-09-19	U-819		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-002	7994220	2029-09-19	U-819		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-003	7994220	2029-09-19	U-819		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022256-004	7994220	2029-09-19	U-819		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-002	7994220	2029-09-19	U-819		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-003	7994220	2029-09-19	U-819		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022256-004	7994220	2029-09-19	U-819		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-002	7994220	2029-09-19	U-819		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-003	7994220	2029-09-19	U-819		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022256-004	7994220	2029-09-19	U-819		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-002	7994220	2029-09-19	U-819		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-003	7994220	2029-09-19	U-819		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022256-004	7994220	2029-09-19	U-819		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022256-001	7994220	2029-09-19	U-819	2011-09-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-002	7994220	2029-09-19	U-819		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-003	7994220	2029-09-19	U-819		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022256-004	7994220	2029-09-19	U-819		`d06236e962d9…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-9993-2	2021-01-29	C162847	48780-1	ba0f9c33-5549-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use Savella safely and effectively. See full prescribing information for Savella. Savella® (milnacipran HCl) Tablets Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-9993-2	Savella	60 in 1 BOTTLE	TABLET, FILM COATED	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-9993-2	EA - Each	50436-9993	86449f41-0280-4a9b-9560-2009e09b616b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
milnacipran hydrochloride	ACTIVE INGREDIENT	RNZ43O5WW5	SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	2
milnacipran	ACTIVE MOIETY	G56VK1HF36	SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	2
carboxymethylcellulose calcium	INACTIVE INGREDIENT	UTY7PDF93L	SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	2
colloidal silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	2
povidone	INACTIVE INGREDIENT	FZ989GH94E	SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-9993	SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]	4	Legacy NDC, 1 package rows	20170313_c288bf12-cbab-4bc5-afb8-9853c0a15792.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Milnacipran Hydrochloride	MILNACIPRAN HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	b66b1850-0d2a-41d6-b0ad-c676166394c7	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022256 application number: NDA022256
Savella	MILNACIPRAN HYDROCHLORIDE	Cardinal Health 107, LLC	8b720a1e-034b-4583-b80d-105a794cce74	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022256 application number: NDA022256
Savella	MILNACIPRAN HYDROCHLORIDE	Allergan, Inc.	16a4a314-f97e-4e91-95e9-576a3773d284	2025-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022256 application number: NDA022256

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
833147	milnacipran HCl 25 MG Oral Tablet	PSN	c288bf12-cbab-4bc5-afb8-9853c0a15792	4
833149	Savella 25 MG Oral Tablet	PSN	c288bf12-cbab-4bc5-afb8-9853c0a15792	4
833149	milnacipran hydrochloride 25 MG Oral Tablet [Savella]	SBD	c288bf12-cbab-4bc5-afb8-9853c0a15792	4
833147	milnacipran hydrochloride 25 MG Oral Tablet	SCD	c288bf12-cbab-4bc5-afb8-9853c0a15792	4
833149	Savella 25 MG Oral Tablet	SY	c288bf12-cbab-4bc5-afb8-9853c0a15792	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-9993-2	50436999302	60 in 1 BOTTLE	Historical