Cobenfy

Product NDC: 0003-0125
Requested package NDC: 0003-0125-14
11-digit product format: 000030125
Labeler code: 0003
Product ID: 0003-0125_51277f95-1b88-42b7-9e2b-7a0bfd609ccf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: xanomeline and trospium chloride
Dosage form: CAPSULE, COATED PELLETS
Route: ORAL
Labeler: E.R. Squibb & Sons, L.L.C.
Application: NDA216158
Marketing category: NDA
Marketing start: 2024-09-27
Substance: TROSPIUM CHLORIDE; XANOMELINE
Active strength: 30; 125 mg/1; mg/1
Pharmacologic classes: Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216158-001	COBENFY	TROSPIUM CHLORIDE; XANOMELINE TARTRATE	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26
N216158-002	COBENFY	TROSPIUM CHLORIDE; XANOMELINE TARTRATE	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26
N216158-003	COBENFY	TROSPIUM CHLORIDE; XANOMELINE TARTRATE	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD	2024-09-26

Orange Book patents#

Current patent rows page 1 of 1 · 33 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216158-001	10238643	2030-07-21		Drug product	2024-10-25
N216158-001	10265311	2030-07-21	U-3513		2024-10-25
N216158-001	10369143	2030-07-21	U-3513		2024-10-25
N216158-001	10369144	2030-07-21	U-3513	Drug product	2024-10-25
N216158-001	10695339	2030-07-21	U-3513		2024-10-25
N216158-001	10925832	2039-09-27		Drug product	2024-10-25
N216158-001	10933020	2039-09-27	U-3513	Drug product	2024-10-25
N216158-001	11452692	2039-09-27	U-3513		2024-10-25
N216158-001	11471413	2039-09-27	U-3513		2024-10-25
N216158-001	11890378	2039-09-27	U-3513	Drug product	2024-10-25
N216158-001	12558317	2039-10-29		Drug product	2026-03-24
N216158-002	10238643	2030-07-21		Drug product	2024-10-25
N216158-002	10265311	2030-07-21	U-3513		2024-10-25
N216158-002	10369143	2030-07-21	U-3513		2024-10-25
N216158-002	10369144	2030-07-21	U-3513	Drug product	2024-10-25
N216158-002	10695339	2030-07-21	U-3513		2024-10-25
N216158-002	10925832	2039-09-27		Drug product	2024-10-25
N216158-002	10933020	2039-09-27	U-3513	Drug product	2024-10-25
N216158-002	11452692	2039-09-27	U-3513		2024-10-25
N216158-002	11471413	2039-09-27	U-3513		2024-10-25
N216158-002	11890378	2039-09-27	U-3513	Drug product	2024-10-25
N216158-002	12558317	2039-10-29		Drug product	2026-03-24
N216158-003	10238643	2030-07-21		Drug product	2024-10-25
N216158-003	10265311	2030-07-21	U-3513		2024-10-25
N216158-003	10369143	2030-07-21	U-3513		2024-10-25
N216158-003	10369144	2030-07-21	U-3513	Drug product	2024-10-25
N216158-003	10695339	2030-07-21	U-3513		2024-10-25
N216158-003	10925832	2039-09-27		Drug product	2024-10-25
N216158-003	10933020	2039-09-27	U-3513	Drug product	2024-10-25
N216158-003	11452692	2039-09-27	U-3513		2024-10-25
N216158-003	11471413	2039-09-27	U-3513		2024-10-25
N216158-003	11890378	2039-09-27	U-3513	Drug product	2024-10-25
N216158-003	12558317	2039-10-29		Drug product	2026-03-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216158-001	NCE	2029-09-26
N216158-002	NCE	2029-09-26
N216158-003	NCE	2029-09-26

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216158-001	COBENFY	20MG;EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216158-002	COBENFY	20MG;EQ 100MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216158-003	COBENFY	30MG;EQ 125MG BASE	CAPSULE / ORAL	RLD	2024-09-26	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 273 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216158-001	10238643	2030-07-21		Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	10265311	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	10369143	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	10369144	2030-07-21	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	10695339	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	10925832	2039-09-27		Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	10933020	2039-09-27	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	11452692	2039-09-27	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	11471413	2039-09-27	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-001	11890378	2039-09-27	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10238643	2030-07-21		Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10265311	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10369143	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10369144	2030-07-21	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10695339	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10925832	2039-09-27		Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	10933020	2039-09-27	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	11452692	2039-09-27	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	11471413	2039-09-27	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	11890378	2039-09-27	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10238643	2030-07-21		Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10265311	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10369143	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10369144	2030-07-21	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10695339	2030-07-21	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10925832	2039-09-27		Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	10933020	2039-09-27	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	11452692	2039-09-27	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	11471413	2039-09-27	U-3513		2024-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	11890378	2039-09-27	U-3513	Drug product	2024-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10238643	2030-07-21		Drug product	2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10265311	2030-07-21	U-3513		2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10369143	2030-07-21	U-3513		2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10369144	2030-07-21	U-3513	Drug product	2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10695339	2030-07-21	U-3513		2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10925832	2039-09-27		Drug product	2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	10933020	2039-09-27	U-3513	Drug product	2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	11452692	2039-09-27	U-3513		2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	11471413	2039-09-27	U-3513		2024-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	11890378	2039-09-27	U-3513	Drug product	2024-10-25	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216158-001	NCE	2029-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-002	NCE	2029-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216158-003	NCE	2029-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-001	NCE	2029-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-002	NCE	2029-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216158-003	NCE	2029-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216158-001	NCE	2029-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216158-002	NCE	2029-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216158-003	NCE	2029-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216158-001	NCE	2029-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216158-002	NCE	2029-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216158-003	NCE	2029-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216158-001	NCE	2029-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216158-002	NCE	2029-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216158-003	NCE	2029-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216158-001	NCE	2029-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216158-002	NCE	2029-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216158-003	NCE	2029-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216158-001	NCE	2029-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216158-002	NCE	2029-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216158-003	NCE	2029-09-26	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216158-001	NCE	2029-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216158-002	NCE	2029-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216158-003	NCE	2029-09-26	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216158-001	NCE	2029-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216158-002	NCE	2029-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216158-003	NCE	2029-09-26	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
XANOMELINE	30 mg/1
TROSPIUM CHLORIDE	125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1E6682427E	Internal UNII lookup
9ORI6L73CJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2694843	Internal RxNorm lookup
2694850	Internal RxNorm lookup
2694853	Internal RxNorm lookup
2694855	Internal RxNorm lookup
2694989	Internal RxNorm lookup
2694991	Internal RxNorm lookup
2694992	Internal RxNorm lookup
2694993	Internal RxNorm lookup
2695671	Internal RxNorm lookup
2695672	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
8f0e73bf-6025-44f6-ab64-0983322de0df	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bfc41181-d174-476d-8a52-4a385ae9213d	Product name	1	20250423
7c473500-2ad1-88f9-e10e-6f8136eda28c	Product name	4	20250226
9151f483-8353-9cd4-427d-86fb1b5ba7ea	Product name	4	20211027
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0003-0125-14	Cobenfy	14 in 1 BLISTER PACK	CAPSULE, COATED PELLETS	14		4
0003-0125-60	Cobenfy	60 in 1 BOTTLE	CAPSULE, COATED PELLETS	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0003-0125-60	EA - Each	0003-0125	e95d864b-3475-414b-b3c6-ade06b7ccc6a	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0003-0125	COBENFY (XANOMELINE AND TROSPIUM CHLORIDE) CAPSULE, COATED PELLETS COBENFY (XANOMELINE AND TROSPIUM CHLORIDE) KIT [E.R. SQUIBB & SONS, L.L.C.]	3	Current NDC, 2 package rows	20241019_8f0e73bf-6025-44f6-ab64-0983322de0df.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
Cobenfy	XANOMELINE AND TROSPIUM CHLORIDE	E.R. Squibb & Sons, L.L.C.	8f0e73bf-6025-44f6-ab64-0983322de0df	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216158 application number: NDA216158 ndc (package): 0003-0125-14 ndc (product): 0003-0125 ndc11 (package): 00003012514

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1E6682427E	TROSPIUM CHLORIDE	10405-02-4	TROSPIUM CHLORIDE
9ORI6L73CJ	XANOMELINE	131986-45-3	XANOMELINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2695672	{10 (trospium chloride 20 MG / xanomeline 100 MG Oral Capsule [Cobenfy]) / 4 (trospium chloride 20 MG / xanomeline 50 MG Oral Capsule [Cobenfy]) } Pack [Cobenfy 7-Day Titration Pack - 50 MG/20 MG (4), 100 MG/20 MG (10) 14 Count]	BPCK	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694993	{52 (trospium chloride 20 MG / xanomeline 100 MG Oral Capsule [Cobenfy]) / 4 (trospium chloride 20 MG / xanomeline 50 MG Oral Capsule [Cobenfy]) } Pack [Cobenfy 28-Day Starter Kit]	BPCK	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2695671	{10 (trospium chloride 20 MG / xanomeline 100 MG Oral Capsule) / 4 (trospium chloride 20 MG / xanomeline 50 MG Oral Capsule) } Pack	GPCK	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694992	{52 (trospium chloride 20 MG / xanomeline 100 MG Oral Capsule) / 4 (trospium chloride 20 MG / xanomeline 50 MG Oral Capsule) } Pack	GPCK	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694991	COBENFY 100 MG / 20 MG Oral Capsule	PSN	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694855	COBENFY 125 MG / 30 MG Oral Capsule	PSN	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694993	COBENFY 28-Day Starter Kit 56 Count	PSN	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694850	COBENFY 50 MG / 20 MG Oral Capsule	PSN	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2695672	COBENFY 7-Day Titration Pack 14 Count	PSN	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694989	xanomeline 100 MG / trospium chloride 20 MG Oral Capsule	PSN	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694853	xanomeline 125 MG / trospium chloride 30 MG Oral Capsule	PSN	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694843	xanomeline 50 MG / trospium chloride 20 MG Oral Capsule	PSN	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694992	xanomeline/trospium chloride 28-Day Starter Kit 56 Count	PSN	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2695671	xanomeline/trospium chloride 7-Day Titration Pack - 50 MG/20 MG (4), 100 MG/20 MG (10) 14 Count	PSN	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694991	trospium chloride 20 MG / xanomeline 100 MG Oral Capsule [Cobenfy]	SBD	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694850	trospium chloride 20 MG / xanomeline 50 MG Oral Capsule [Cobenfy]	SBD	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694855	trospium chloride 30 MG / xanomeline 125 MG Oral Capsule [Cobenfy]	SBD	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694989	trospium chloride 20 MG / xanomeline 100 MG Oral Capsule	SCD	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694843	trospium chloride 20 MG / xanomeline 50 MG Oral Capsule	SCD	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694853	trospium chloride 30 MG / xanomeline 125 MG Oral Capsule	SCD	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694991	Cobenfy (trospium chloride 20 MG / xanomeline 100 MG) Oral Capsule	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694850	Cobenfy (trospium chloride 20 MG / xanomeline 50 MG) Oral Capsule	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694855	Cobenfy (trospium chloride 30 MG / xanomeline 125 MG) Oral Capsule	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694991	Cobenfy 100 MG / 20 MG (equivalent to xanomeline tartrate 153.3 MG / trospium 18.3 MG) Oral Capsule	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694855	Cobenfy 125 MG / 30 MG (equivalent to xanomeline tartrate 191.7 MG / trospium 27.5 MG) Oral Capsule	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694993	Cobenfy 28-Day (50 MG/20 MG (4), 100 MG/20 MG (52)) Starter Kit	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694850	Cobenfy 50 MG / 20 MG (equivalent to xanomeline tartrate 76.7 MG / trospium 18.3 MG) Oral Capsule	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2695672	Cobenfy 7-Day Titration Pack - 50 MG/20 MG (4), 100 MG/20 MG (10) 14 Count	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694989	xanomeline 100 MG (equivalent to xanomeline tartrate 153.3 MG) / trospium chloride 20 MG (equivalent to trospium 18.3 MG) Oral Capsule	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694853	xanomeline 125 MG (equivalent to xanomeline tartrate 191.7 MG) / trospium chloride 30 MG (equivalent to trospium 27.5 MG) Oral Capsule	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694843	xanomeline 50 MG (equivalent to xanomeline tartrate 76.7 MG) / trospium chloride 20 MG (trospium 18.3 MG) Oral Capsule	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2694992	xanomeline/trospium chloride 28-Day (50 MG/20 MG (4), 100 MG/20 MG (52)) Starter Kit	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4
2695671	xanomeline/trospium chloride 7-Day Titration Pack - 50 MG/20 MG (4), 100 MG/20 MG (10) 14 Count	SY	8f0e73bf-6025-44f6-ab64-0983322de0df	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0003-0125-14	00003012514	14 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-0125-14)	2024-09-27	Yes	No	Current