Home NDC 0002-4503 FOUNDAYO
Product NDC 0002-4503
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 TE codes 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.
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 Product TE source text 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# 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.
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
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0002-4503-01 00002450301 30 in 1 BOTTLE Historical 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