FOUNDAYO

Product NDC: 0002-4503
Requested package NDC: 0002-4503-31
11-digit product format: 000024503
Labeler code: 0002
Product ID: 0002-4503_ebe44919-a00d-4ea1-a511-18e6a87da34c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: orforglipron
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Eli Lilly and Company
Application: NDA220934
Marketing category: NDA
Marketing start: 2026-04-01
Substance: ORFORGLIPRON CALCIUM
Active strength: 2.5 mg/1
Pharmacologic classes: Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N220934-001	FOUNDAYO	ORFORGLIPRON CALCIUM	EQ 0.8MG BASE	TABLET / ORAL	RLD	2026-04-01
N220934-002	FOUNDAYO	ORFORGLIPRON CALCIUM	EQ 2.5MG BASE	TABLET / ORAL	RLD	2026-04-01
N220934-003	FOUNDAYO	ORFORGLIPRON CALCIUM	EQ 5.5MG BASE	TABLET / ORAL	RLD	2026-04-01
N220934-004	FOUNDAYO	ORFORGLIPRON CALCIUM	EQ 9MG BASE	TABLET / ORAL	RLD	2026-04-01
N220934-005	FOUNDAYO	ORFORGLIPRON CALCIUM	EQ 14.5MG BASE	TABLET / ORAL	RLD	2026-04-01
N220934-006	FOUNDAYO	ORFORGLIPRON CALCIUM	EQ 17.2MG BASE	TABLET / ORAL	RLD, RS	2026-04-01

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N220934-001	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14
N220934-002	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14
N220934-003	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14
N220934-004	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14
N220934-005	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14
N220934-006	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N220934-001	NCE	2031-04-01
N220934-002	NCE	2031-04-01
N220934-003	NCE	2031-04-01
N220934-004	NCE	2031-04-01
N220934-005	NCE	2031-04-01
N220934-006	NCE	2031-04-01

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
2026-09-14 22:38:34	2026-08	N220934-001	FOUNDAYO	EQ 0.8MG BASE	TABLET / ORAL	RLD	2026-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-002	FOUNDAYO	EQ 2.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-003	FOUNDAYO	EQ 5.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-004	FOUNDAYO	EQ 9MG BASE	TABLET / ORAL	RLD	2026-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-005	FOUNDAYO	EQ 14.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-006	FOUNDAYO	EQ 17.2MG BASE	TABLET / ORAL	RLD, RS	2026-04-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220934-001	FOUNDAYO	EQ 0.8MG BASE	TABLET / ORAL	RLD	2026-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-002	FOUNDAYO	EQ 2.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-003	FOUNDAYO	EQ 5.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-004	FOUNDAYO	EQ 9MG BASE	TABLET / ORAL	RLD	2026-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-005	FOUNDAYO	EQ 14.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-006	FOUNDAYO	EQ 17.2MG BASE	TABLET / ORAL	RLD, RS	2026-04-01	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-001	FOUNDAYO	EQ 0.8MG BASE	TABLET / ORAL	RLD	2026-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-002	FOUNDAYO	EQ 2.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-003	FOUNDAYO	EQ 5.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-004	FOUNDAYO	EQ 9MG BASE	TABLET / ORAL	RLD	2026-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-005	FOUNDAYO	EQ 14.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-006	FOUNDAYO	EQ 17.2MG BASE	TABLET / ORAL	RLD, RS	2026-04-01	`a50c72e98297…`

Observed Orange Book patent history#

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	N220934-001	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-002	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-003	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-004	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-005	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-006	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220934-001	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-002	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-003	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-004	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-005	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-006	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-001	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-002	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-003	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-004	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-005	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-006	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N220934-001	NCE	2031-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-002	NCE	2031-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-003	NCE	2031-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-004	NCE	2031-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-005	NCE	2031-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-006	NCE	2031-04-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220934-001	NCE	2031-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-002	NCE	2031-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-003	NCE	2031-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-004	NCE	2031-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-005	NCE	2031-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-006	NCE	2031-04-01	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-001	NCE	2031-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-002	NCE	2031-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-003	NCE	2031-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-004	NCE	2031-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-005	NCE	2031-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-006	NCE	2031-04-01	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ORFORGLIPRON CALCIUM	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VI5M9OZV2X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2739844	Internal RxNorm lookup
2739850	Internal RxNorm lookup
2739852	Internal RxNorm lookup
2739854	Internal RxNorm lookup
2739856	Internal RxNorm lookup
2739858	Internal RxNorm lookup
2739860	Internal RxNorm lookup
2739862	Internal RxNorm lookup
2739864	Internal RxNorm lookup
2739866	Internal RxNorm lookup
2739868	Internal RxNorm lookup
2739870	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
8ac446c5-feba-474f-a103-23facb9b5c62	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0002-4503-01	FOUNDAYO	30 in 1 BOTTLE	TABLET, FILM COATED	30		5
0002-4503-31	FOUNDAYO	1 in 1 CARTON	TABLET, FILM COATED	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-4503-01	EA - Each	0002-4503	a4d88124-2011-4909-bfe2-242282056782	1	2026-05-22
0002-4503-31	EA - Each	0002-4503	b2f996cc-ee44-484a-92d0-25a5fdad7b23	1	2026-04-20

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
FOUNDAYO	ORFORGLIPRON	Eli Lilly and Company	8ac446c5-feba-474f-a103-23facb9b5c62	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 220934 application number: NDA220934 ndc (package): 0002-4503-31 ndc (product): 0002-4503 ndc11 (package): 00002450331

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2739850	Foundayo 0.8 MG Oral Tablet	PSN	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739866	Foundayo 14.5 MG Oral Tablet	PSN	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739870	Foundayo 17.2 MG Oral Tablet	PSN	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739854	Foundayo 2.5 MG Oral Tablet	PSN	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739858	Foundayo 5.5 MG Oral Tablet	PSN	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739862	Foundayo 9 MG Oral Tablet	PSN	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739844	orforglipron 0.8 MG Oral Tablet	PSN	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739864	orforglipron 14.5 MG Oral Tablet	PSN	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739868	orforglipron 17.2 MG Oral Tablet	PSN	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739852	orforglipron 2.5 MG Oral Tablet	PSN	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739856	orforglipron 5.5 MG Oral Tablet	PSN	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739860	orforglipron 9 MG Oral Tablet	PSN	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739850	orforglipron 0.8 MG Oral Tablet [Foundayo]	SBD	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739866	orforglipron 14.5 MG Oral Tablet [Foundayo]	SBD	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739870	orforglipron 17.2 MG Oral Tablet [Foundayo]	SBD	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739854	orforglipron 2.5 MG Oral Tablet [Foundayo]	SBD	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739858	orforglipron 5.5 MG Oral Tablet [Foundayo]	SBD	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739862	orforglipron 9 MG Oral Tablet [Foundayo]	SBD	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739844	orforglipron 0.8 MG Oral Tablet	SCD	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739864	orforglipron 14.5 MG Oral Tablet	SCD	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739868	orforglipron 17.2 MG Oral Tablet	SCD	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739852	orforglipron 2.5 MG Oral Tablet	SCD	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739856	orforglipron 5.5 MG Oral Tablet	SCD	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739860	orforglipron 9 MG Oral Tablet	SCD	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739850	Foundayo 0.8 MG (equivalent to orforglipron calcium 0.817 MG) Oral Tablet	SY	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739866	Foundayo 14.5 MG (equivalent to orforglipron calcium 14.81 MG) Oral Tablet	SY	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739870	Foundayo 17.2 MG (equivalent to orforglipron calcium 17.57 MG) Oral Tablet	SY	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739854	Foundayo 2.5 MG (equivalent to orforglipron calcium 2.554 MG) Oral Tablet	SY	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739858	Foundayo 5.5 MG (equivalent to orforglipron calcium 5.619 MG) Oral Tablet	SY	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739862	Foundayo 9 MG (equivalent to orforglipron calcium 9.194 MG) Oral Tablet	SY	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739844	orforglipron 0.8 MG (equivalent to orforglipron calcium 0.817 MG) Oral Tablet	SY	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739864	orforglipron 14.5 MG (equivalent to orforglipron calcium 14.81 MG) Oral Tablet	SY	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739868	orforglipron 17.2 MG (equivalent to orforglipron calcium 17.57 MG) Oral Tablet	SY	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739852	orforglipron 2.5 MG (equivalent to orforglipron calcium 2.554 MG) Oral Tablet	SY	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739856	orforglipron 5.5 MG (equivalent to orforglipron calcium 5.619 MG) Oral Tablet	SY	8ac446c5-feba-474f-a103-23facb9b5c62	5
2739860	orforglipron 9 MG (equivalent to orforglipron calcium 9.194 MG) Oral Tablet	SY	8ac446c5-feba-474f-a103-23facb9b5c62	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0002-4503-31	00002450331	1 BOTTLE in 1 CARTON (0002-4503-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4503-01)	1 bottle	2026-04-01	No	No	Current