Zepbound

Product NDC
0002-6523
11-digit product format
000026523
Labeler code
0002
Product ID
0002-6523_86a64015-7f78-4281-8b7f-579b6c3dc1f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tirzepatide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
NDA217806
Marketing category
NDA
Marketing start
2026-01-07
Substance
TIRZEPATIDE
Active strength
20.8 mg/mL
Pharmacologic classes
G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [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 42.

Orange Book products#

Current product rows page 1 of 1 · 24 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217806-001ZEPBOUND (AUTOINJECTOR)TIRZEPATIDE2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08
N217806-002ZEPBOUND (AUTOINJECTOR)TIRZEPATIDE5MG/0.5ML (5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08
N217806-003ZEPBOUND (AUTOINJECTOR)TIRZEPATIDE7.5MG/0.5ML (7.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08
N217806-004ZEPBOUND (AUTOINJECTOR)TIRZEPATIDE10MG/0.5ML (10MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08
N217806-005ZEPBOUND (AUTOINJECTOR)TIRZEPATIDE12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08
N217806-006ZEPBOUND (AUTOINJECTOR)TIRZEPATIDE15MG/0.5ML (15MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08
N217806-007ZEPBOUNDTIRZEPATIDE2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28
N217806-008ZEPBOUNDTIRZEPATIDE5MG/0.5ML (5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28
N217806-009ZEPBOUNDTIRZEPATIDE7.5MG/0.5ML (7.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28
N217806-010ZEPBOUNDTIRZEPATIDE10MG/0.5ML (10MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28
N217806-011ZEPBOUNDTIRZEPATIDE12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28
N217806-012ZEPBOUNDTIRZEPATIDE15MG/0.5ML (15MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28
N217806-013ZEPBOUNDTIRZEPATIDE10MG/2.4ML (4.17MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N217806-014ZEPBOUNDTIRZEPATIDE20MG/2.4ML (8.33MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N217806-015ZEPBOUNDTIRZEPATIDE30MG/2.4ML (12.5MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N217806-016ZEPBOUNDTIRZEPATIDE40MG/2.4ML (16.7MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N217806-017ZEPBOUNDTIRZEPATIDE50MG/2.4ML (20.8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N217806-018ZEPBOUNDTIRZEPATIDE60MG/2.4ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07
N217806-019ZEPBOUND KWIKPENTIRZEPATIDE10MG/2.4ML (4.17MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N217806-020ZEPBOUND KWIKPENTIRZEPATIDE20MG/2.4ML (8.33MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N217806-021ZEPBOUND KWIKPENTIRZEPATIDE30MG/2.4ML (12.5MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N217806-022ZEPBOUND KWIKPENTIRZEPATIDE40MG/2.4ML (16.7MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N217806-023ZEPBOUND KWIKPENTIRZEPATIDE50MG/2.4ML (20.8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20
N217806-024ZEPBOUND KWIKPENTIRZEPATIDE60MG/2.4ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20

Orange Book patents#

Current patent rows page 1 of 5 · 348 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217806-00194747802036-05-13Drug substance, Drug product2023-12-07
N217806-001113578202039-06-14Drug product2023-12-07
N217806-001119186232039-06-14U-38552024-03-28
N217806-001124537562039-06-14Drug product2025-11-17
N217806-001126294042039-06-14U-4531Drug product2026-06-05
N217806-001126294042039-06-14U-4532Drug product2026-06-05
N217806-001123433822039-07-22U-42272025-07-25
N217806-001123433822039-07-22U-42282025-07-25
N217806-001123433822039-07-22U-44092025-07-25
N217806-001123433822039-07-22U-44102025-07-25
N217806-001124537582039-07-22U-43082025-11-17
N217806-001124537582039-07-22U-43092025-11-17
N217806-001124537582039-07-22U-43102025-11-17
N217806-001124537582039-07-22U-43112025-11-17
N217806-001126167402039-07-22U-44972026-05-05
N217806-001126167402039-07-22U-44982026-05-05
N217806-001126167402039-07-22U-44992026-05-05
N217806-00294747802036-05-13Drug substance, Drug product2023-12-07
N217806-002113578202039-06-14Drug product2023-12-07
N217806-002119186232039-06-14U-38552024-03-28
N217806-002124537562039-06-14Drug product2025-11-17
N217806-002126294042039-06-14U-4531Drug product2026-06-05
N217806-002126294042039-06-14U-4532Drug product2026-06-05
N217806-002123433822039-07-22U-42272025-07-25
N217806-002123433822039-07-22U-42282025-07-25
N217806-002123433822039-07-22U-44092025-07-25
N217806-002123433822039-07-22U-44102025-07-25
N217806-002124537582039-07-22U-43082025-11-17
N217806-002124537582039-07-22U-43092025-11-17
N217806-002124537582039-07-22U-43102025-11-17
N217806-002124537582039-07-22U-43112025-11-17
N217806-002126167402039-07-22U-44972026-05-05
N217806-002126167402039-07-22U-44982026-05-05
N217806-002126167402039-07-22U-44992026-05-05
N217806-00394747802036-05-13Drug substance, Drug product2023-12-07
N217806-003113578202039-06-14Drug product2023-12-07
N217806-003119186232039-06-14U-38552024-03-28
N217806-003124537562039-06-14Drug product2025-11-17
N217806-003126294042039-06-14U-4531Drug product2026-06-05
N217806-003126294042039-06-14U-4532Drug product2026-06-05
N217806-003123433822039-07-22U-42272025-07-25
N217806-003123433822039-07-22U-42282025-07-25
N217806-003123433822039-07-22U-44092025-07-25
N217806-003123433822039-07-22U-44102025-07-25
N217806-003124537582039-07-22U-43082025-11-17
N217806-003124537582039-07-22U-43092025-11-17
N217806-003124537582039-07-22U-43102025-11-17
N217806-003124537582039-07-22U-43112025-11-17
N217806-003126167402039-07-22U-44972026-05-05
N217806-003126167402039-07-22U-44982026-05-05
N217806-003126167402039-07-22U-44992026-05-05
N217806-00494747802036-05-13Drug substance, Drug product2023-12-07
N217806-004113578202039-06-14Drug product2023-12-07
N217806-004119186232039-06-14U-38552024-03-28
N217806-004124537562039-06-14Drug product2025-11-17
N217806-004126294042039-06-14U-4531Drug product2026-06-05
N217806-004126294042039-06-14U-4532Drug product2026-06-05
N217806-004123433822039-07-22U-42272025-07-25
N217806-004123433822039-07-22U-42282025-07-25
N217806-004123433822039-07-22U-44092025-07-25
N217806-004123433822039-07-22U-44102025-07-25
N217806-004124537582039-07-22U-43082025-11-17
N217806-004124537582039-07-22U-43092025-11-17
N217806-004124537582039-07-22U-43102025-11-17
N217806-004124537582039-07-22U-43112025-11-17
N217806-004126167402039-07-22U-44972026-05-05
N217806-004126167402039-07-22U-44982026-05-05
N217806-004126167402039-07-22U-44992026-05-05
N217806-00594747802036-05-13Drug substance, Drug product2023-12-07
N217806-005113578202039-06-14Drug product2023-12-07
N217806-005119186232039-06-14U-38552024-03-28
N217806-005124537562039-06-14Drug product2025-11-17
N217806-005126294042039-06-14U-4531Drug product2026-06-05
N217806-005126294042039-06-14U-4532Drug product2026-06-05
N217806-005123433822039-07-22U-42272025-07-25
N217806-005123433822039-07-22U-42282025-07-25
N217806-005123433822039-07-22U-44092025-07-25
N217806-005123433822039-07-22U-44102025-07-25
N217806-005124537582039-07-22U-43082025-11-17
N217806-005124537582039-07-22U-43092025-11-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 78 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217806-001NP2026-11-08
N217806-001NCE2027-05-13
N217806-001M-822027-10-18
N217806-001I-9582027-12-20
N217806-002NP2026-11-08
N217806-002NCE2027-05-13
N217806-002M-822027-10-18
N217806-002I-9582027-12-20
N217806-003NP2026-11-08
N217806-003NCE2027-05-13
N217806-003M-822027-10-18
N217806-003I-9582027-12-20
N217806-004NP2026-11-08
N217806-004NCE2027-05-13
N217806-004M-822027-10-18
N217806-004I-9582027-12-20
N217806-005NP2026-11-08
N217806-005NCE2027-05-13
N217806-005M-822027-10-18
N217806-005I-9582027-12-20
N217806-006NP2026-11-08
N217806-006NCE2027-05-13
N217806-006M-822027-10-18
N217806-006I-9582027-12-20
N217806-007NCE2027-05-13
N217806-007M-822027-10-18
N217806-007I-9582027-12-20
N217806-008NCE2027-05-13
N217806-008M-822027-10-18
N217806-008I-9582027-12-20
N217806-009NCE2027-05-13
N217806-009M-822027-10-18
N217806-009I-9582027-12-20
N217806-010NCE2027-05-13
N217806-010M-822027-10-18
N217806-010I-9582027-12-20
N217806-011NCE2027-05-13
N217806-011M-822027-10-18
N217806-011I-9582027-12-20
N217806-012NCE2027-05-13
N217806-012M-822027-10-18
N217806-012I-9582027-12-20
N217806-013NCE2027-05-13
N217806-013M-822027-10-18
N217806-013I-9582027-12-20
N217806-014NCE2027-05-13
N217806-014M-822027-10-18
N217806-014I-9582027-12-20
N217806-015NCE2027-05-13
N217806-015M-822027-10-18
N217806-015I-9582027-12-20
N217806-016NCE2027-05-13
N217806-016M-822027-10-18
N217806-016I-9582027-12-20
N217806-017NCE2027-05-13
N217806-017M-822027-10-18
N217806-017I-9582027-12-20
N217806-018NCE2027-05-13
N217806-018M-822027-10-18
N217806-018I-9582027-12-20
N217806-019NCE2027-05-13
N217806-019M-822027-10-18
N217806-019I-9582027-12-20
N217806-020NCE2027-05-13
N217806-020M-822027-10-18
N217806-020I-9582027-12-20
N217806-021NCE2027-05-13
N217806-021M-822027-10-18
N217806-021I-9582027-12-20
N217806-022NCE2027-05-13
N217806-022M-822027-10-18
N217806-022I-9582027-12-20
N217806-023NCE2027-05-13
N217806-023M-822027-10-18
N217806-023I-9582027-12-20
N217806-024NCE2027-05-13
N217806-024M-822027-10-18
N217806-024I-9582027-12-20

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N217806-001ZEPBOUND (AUTOINJECTOR)2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002ZEPBOUND (AUTOINJECTOR)5MG/0.5ML (5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-003ZEPBOUND (AUTOINJECTOR)7.5MG/0.5ML (7.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-004ZEPBOUND (AUTOINJECTOR)10MG/0.5ML (10MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-005ZEPBOUND (AUTOINJECTOR)12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-006ZEPBOUND (AUTOINJECTOR)15MG/0.5ML (15MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-007ZEPBOUND2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-008ZEPBOUND5MG/0.5ML (5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-009ZEPBOUND7.5MG/0.5ML (7.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-010ZEPBOUND10MG/0.5ML (10MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-011ZEPBOUND12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-012ZEPBOUND15MG/0.5ML (15MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-013ZEPBOUND10MG/2.4ML (4.17MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-014ZEPBOUND20MG/2.4ML (8.33MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-015ZEPBOUND30MG/2.4ML (12.5MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-016ZEPBOUND40MG/2.4ML (16.7MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-017ZEPBOUND50MG/2.4ML (20.8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-018ZEPBOUND60MG/2.4ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-019ZEPBOUND KWIKPEN10MG/2.4ML (4.17MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-020ZEPBOUND KWIKPEN20MG/2.4ML (8.33MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-021ZEPBOUND KWIKPEN30MG/2.4ML (12.5MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-022ZEPBOUND KWIKPEN40MG/2.4ML (16.7MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-023ZEPBOUND KWIKPEN50MG/2.4ML (20.8MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-024ZEPBOUND KWIKPEN60MG/2.4ML (25MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217806-001ZEPBOUND (AUTOINJECTOR)2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-002ZEPBOUND (AUTOINJECTOR)5MG/0.5ML (5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-003ZEPBOUND (AUTOINJECTOR)7.5MG/0.5ML (7.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-004ZEPBOUND (AUTOINJECTOR)10MG/0.5ML (10MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-005ZEPBOUND (AUTOINJECTOR)12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-006ZEPBOUND (AUTOINJECTOR)15MG/0.5ML (15MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2023-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-007ZEPBOUND2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-008ZEPBOUND5MG/0.5ML (5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-009ZEPBOUND7.5MG/0.5ML (7.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-010ZEPBOUND10MG/0.5ML (10MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-011ZEPBOUND12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-012ZEPBOUND15MG/0.5ML (15MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-013ZEPBOUND10MG/2.4ML (4.17MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-014ZEPBOUND20MG/2.4ML (8.33MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-015ZEPBOUND30MG/2.4ML (12.5MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217806-016ZEPBOUND40MG/2.4ML (16.7MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2026-01-07011fe1cb6892…

Observed Orange Book patent history#

Patent history page 1 of 37 · 1,452 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N217806-00194747802036-05-13Drug substance, Drug product2023-12-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001113578202039-06-14Drug product2023-12-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001119186232039-06-14U-38552024-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001124537562039-06-14Drug product2025-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001126294042039-06-14U-4531Drug product2026-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001126294042039-06-14U-4532Drug product2026-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001123433822039-07-22U-42282025-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001123433822039-07-22U-42272025-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001123433822039-07-22U-44092025-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001123433822039-07-22U-44102025-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001124537582039-07-22U-43082025-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001124537582039-07-22U-43112025-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001124537582039-07-22U-43102025-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001124537582039-07-22U-43092025-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001126167402039-07-22U-44972026-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001126167402039-07-22U-44982026-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001126167402039-07-22U-44992026-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-00294747802036-05-13Drug substance, Drug product2023-12-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002113578202039-06-14Drug product2023-12-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002119186232039-06-14U-38552024-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002124537562039-06-14Drug product2025-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002126294042039-06-14U-4531Drug product2026-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002126294042039-06-14U-4532Drug product2026-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002123433822039-07-22U-42282025-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002123433822039-07-22U-42272025-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002123433822039-07-22U-44102025-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002123433822039-07-22U-44092025-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002124537582039-07-22U-43112025-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002124537582039-07-22U-43102025-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002124537582039-07-22U-43092025-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002124537582039-07-22U-43082025-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002126167402039-07-22U-44972026-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002126167402039-07-22U-44982026-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002126167402039-07-22U-44992026-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-00394747802036-05-13Drug substance, Drug product2023-12-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-003113578202039-06-14Drug product2023-12-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-003119186232039-06-14U-38552024-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-003124537562039-06-14Drug product2025-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-003126294042039-06-14U-4531Drug product2026-06-05caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-003126294042039-06-14U-4532Drug product2026-06-05caaa826d4ba7…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 15 · 588 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N217806-001NP2026-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001NCE2027-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001M-822027-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-001I-9582027-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002NP2026-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002NCE2027-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002M-822027-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-002I-9582027-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-003NP2026-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-003NCE2027-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-003M-822027-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-003I-9582027-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-004NP2026-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-004NCE2027-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-004M-822027-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-004I-9582027-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-005NP2026-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-005NCE2027-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-005M-822027-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-005I-9582027-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-006NP2026-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-006NCE2027-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-006M-822027-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-006I-9582027-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-007NCE2027-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-007M-822027-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-007I-9582027-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-008NCE2027-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-008M-822027-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-008I-9582027-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-009NCE2027-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-009M-822027-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-009I-9582027-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-010NCE2027-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-010M-822027-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-010I-9582027-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-011NCE2027-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-011M-822027-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-011I-9582027-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217806-012NCE2027-05-13caaa826d4ba7…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIRZEPATIDE20.8 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OYN3CCI6QEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 3 · 48 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2601743Internal RxNorm lookup
2601755Internal RxNorm lookup
2601761Internal RxNorm lookup
2601767Internal RxNorm lookup
2601773Internal RxNorm lookup
2601784Internal RxNorm lookup
2644396Internal RxNorm lookup
2644401Internal RxNorm lookup
2644405Internal RxNorm lookup
2644409Internal RxNorm lookup
2644413Internal RxNorm lookup
2644417Internal RxNorm lookup
2669706Internal RxNorm lookup
2669709Internal RxNorm lookup
2669712Internal RxNorm lookup
2669715Internal RxNorm lookup
2669718Internal RxNorm lookup
2669721Internal RxNorm lookup
2679317Internal RxNorm lookup
2679319Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
487cd7e7-434c-4925-99fa-aa80b1cc776bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
764832a6-c731-479b-b340-b4c8813a2a29Product name120250724
079c774f-6797-40bd-b11b-fd311f893a4eProduct name120230124
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-6523-01Zepbound2.4 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.438
0002-6523-11Zepbound1 in 1 CARTONINJECTION, SOLUTION138

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZepboundTIRZEPATIDEEli Lilly and Company487cd7e7-434c-4925-99fa-aa80b1cc776b2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 217806
application number: NDA217806
ndc (product): 0002-6523

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601767tirzepatide 10 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644417tirzepatide 10 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734628tirzepatide 10 MG per dose (40 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601773tirzepatide 12.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644413tirzepatide 12.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734632tirzepatide 12.5 MG per dose (50 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732437tirzepatide 12.5 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601755tirzepatide 15 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644409tirzepatide 15 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734636tirzepatide 15 MG per dose (60 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732442tirzepatide 16.7 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601761tirzepatide 2.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644405tirzepatide 2.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734640tirzepatide 2.5 MG per dose (10 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732446tirzepatide 20.8 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732449tirzepatide 25 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732452tirzepatide 4.17 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601743tirzepatide 5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644401tirzepatide 5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734644tirzepatide 5 MG per dose (20 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2601784tirzepatide 7.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2644396tirzepatide 7.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734623tirzepatide 7.5 MG per dose (30 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732456tirzepatide 8.33 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669715zepbound 10 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679317zepbound 10 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734630zepbound 10 MG per dose (40 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669718zepbound 12.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679319zepbound 12.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734634zepbound 12.5 MG per dose (50 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732440zepbound 12.5 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669721zepbound 15 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679321zepbound 15 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734638zepbound 15 MG per dose (60 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732444zepbound 16.7 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669706zepbound 2.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679323zepbound 2.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734642zepbound 2.5 MG per dose (10 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732448zepbound 20.8 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732450zepbound 25 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732454zepbound 4.17 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669709zepbound 5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679325zepbound 5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734646Zepbound 5 MG per dose (20 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2669712zepbound 7.5 MG in 0.5 ML Auto-InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2679327zepbound 7.5 MG in 0.5 ML InjectionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2734626zepbound 7.5 MG per dose (30 MG in 2.4 ML) Pen InjectorPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732458zepbound 8.33 MG/ML Injectable SolutionPSN487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697090.5 ML tirzepatide 10 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793250.5 ML tirzepatide 10 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697120.5 ML tirzepatide 15 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793270.5 ML tirzepatide 15 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697150.5 ML tirzepatide 20 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793170.5 ML tirzepatide 20 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697180.5 ML tirzepatide 25 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793190.5 ML tirzepatide 25 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697210.5 ML tirzepatide 30 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793210.5 ML tirzepatide 30 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26697060.5 ML tirzepatide 5 MG/ML Auto-Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26793230.5 ML tirzepatide 5 MG/ML Injection [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346262.4 ML tirzepatide 12.5 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346302.4 ML tirzepatide 16.7 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346342.4 ML tirzepatide 20.8 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346382.4 ML tirzepatide 25 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346422.4 ML tirzepatide 4.17 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
27346462.4 ML tirzepatide 8.33 MG/ML Pen Injector [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732440tirzepatide 12.5 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732444tirzepatide 16.7 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732448tirzepatide 20.8 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732450tirzepatide 25 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732454tirzepatide 4.17 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
2732458tirzepatide 8.33 MG/ML Injectable Solution [Zepbound]SBD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26017430.5 ML tirzepatide 10 MG/ML Auto-InjectorSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26444010.5 ML tirzepatide 10 MG/ML InjectionSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26017840.5 ML tirzepatide 15 MG/ML Auto-InjectorSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26443960.5 ML tirzepatide 15 MG/ML InjectionSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26017670.5 ML tirzepatide 20 MG/ML Auto-InjectorSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26444170.5 ML tirzepatide 20 MG/ML InjectionSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26017730.5 ML tirzepatide 25 MG/ML Auto-InjectorSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38
26444130.5 ML tirzepatide 25 MG/ML InjectionSCD487cd7e7-434c-4925-99fa-aa80b1cc776b38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0002-6523-01000026523012.4 mL in 1 VIAL, MULTI-DOSE2.4 mlHistorical
0002-6523-11000026523111 VIAL, MULTI-DOSE in 1 CARTON (0002-6523-11) / 2.4 mL in 1 VIAL, MULTI-DOSE (0002-6523-01) 2026-01-07NoNoCurrent