MOUNJARO

Product NDC: 50090-8021
11-digit product format: 500908021
Labeler code: 50090
Product ID: 50090-8021_7d192f25-180e-4206-9a68-8d7cfd492d10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tirzepatide
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: A-S Medication Solutions
Application: NDA215866
Marketing category: NDA
Marketing start: 2022-05-13
Substance: TIRZEPATIDE
Active strength: 10 mg/.5mL
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215866-001	MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13
N215866-002	MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13
N215866-003	MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13
N215866-004	MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13
N215866-005	MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13
N215866-006	MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13
N215866-007	MOUNJARO	TIRZEPATIDE	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28
N215866-008	MOUNJARO	TIRZEPATIDE	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28
N215866-009	MOUNJARO	TIRZEPATIDE	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28
N215866-010	MOUNJARO	TIRZEPATIDE	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28
N215866-011	MOUNJARO	TIRZEPATIDE	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28
N215866-012	MOUNJARO	TIRZEPATIDE	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28
N215866-013	MOUNJARO	TIRZEPATIDE	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N215866-014	MOUNJARO	TIRZEPATIDE	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N215866-015	MOUNJARO	TIRZEPATIDE	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N215866-016	MOUNJARO	TIRZEPATIDE	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N215866-017	MOUNJARO	TIRZEPATIDE	50MG/2.4ML (20.8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N215866-018	MOUNJARO	TIRZEPATIDE	60MG/2.4ML (25MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N215866-019	MOUNJARO KWIKPEN	TIRZEPATIDE	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N215866-020	MOUNJARO KWIKPEN	TIRZEPATIDE	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N215866-021	MOUNJARO KWIKPEN	TIRZEPATIDE	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N215866-022	MOUNJARO KWIKPEN	TIRZEPATIDE	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N215866-023	MOUNJARO KWIKPEN	TIRZEPATIDE	50MG/2.4ML (20.8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N215866-024	MOUNJARO KWIKPEN	TIRZEPATIDE	60MG/2.4ML (25MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20

Orange Book patents#

Current patent rows page 1 of 6 · 480 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215866-001	9474780	2036-05-13	U-4374	Drug substance, Drug product	2022-06-09
N215866-001	11357820	2039-06-14		Drug product	2022-06-30
N215866-001	12453755	2039-06-14	U-4375		2025-11-17
N215866-001	12453755	2039-06-14	U-4376		2025-11-17
N215866-001	12453755	2039-06-14	U-4377		2025-11-17
N215866-001	12453755	2039-06-14	U-4378		2025-11-17
N215866-001	12453755	2039-06-14	U-4379		2025-11-17
N215866-001	12453755	2039-06-14	U-4380		2025-11-17
N215866-001	12453755	2039-06-14	U-4381		2025-11-17
N215866-001	12453755	2039-06-14	U-4382		2025-11-17
N215866-001	12453755	2039-06-14	U-4383		2025-11-17
N215866-001	12453755	2039-06-14	U-4384		2025-11-17
N215866-001	12453755	2039-06-14	U-4385		2025-11-17
N215866-001	12453755	2039-06-14	U-4386		2025-11-17
N215866-001	12453756	2039-06-14		Drug product	2025-11-17
N215866-001	12629404	2039-06-14	U-4533	Drug product	2026-06-05
N215866-001	12629404	2039-06-14	U-4534	Drug product	2026-06-05
N215866-001	12343382	2039-07-22	U-4229		2025-07-25
N215866-001	12343382	2039-07-22	U-4230		2025-07-25
N215866-001	12343382	2039-07-22	U-4231		2025-07-25
N215866-001	12343382	2039-07-22	U-4232		2025-07-25
N215866-001	12343382	2039-07-22	U-4400		2025-07-25
N215866-001	12343382	2039-07-22	U-4401		2025-07-25
N215866-001	12616740	2039-07-22	U-4500		2026-05-05
N215866-001	12616740	2039-07-22	U-4501		2026-05-05
N215866-001	12616740	2039-07-22	U-4502		2026-05-05
N215866-001	12295987	2041-12-30	U-4192		2025-06-11
N215866-001	12295987	2041-12-30	U-4193		2025-06-11
N215866-002	9474780	2036-05-13	U-4374	Drug substance, Drug product	2022-06-09
N215866-002	11357820	2039-06-14		Drug product	2022-06-30
N215866-002	12453755	2039-06-14	U-4375		2025-11-17
N215866-002	12453755	2039-06-14	U-4376		2025-11-17
N215866-002	12453755	2039-06-14	U-4377		2025-11-17
N215866-002	12453755	2039-06-14	U-4378		2025-11-17
N215866-002	12453755	2039-06-14	U-4379		2025-11-17
N215866-002	12453755	2039-06-14	U-4380		2025-11-17
N215866-002	12453755	2039-06-14	U-4381		2025-11-17
N215866-002	12453755	2039-06-14	U-4382		2025-11-17
N215866-002	12453755	2039-06-14	U-4383		2025-11-17
N215866-002	12453755	2039-06-14	U-4384		2025-11-17
N215866-002	12453755	2039-06-14	U-4385		2025-11-17
N215866-002	12453755	2039-06-14	U-4386		2025-11-17
N215866-002	12453756	2039-06-14		Drug product	2025-11-17
N215866-002	12629404	2039-06-14	U-4533	Drug product	2026-06-05
N215866-002	12629404	2039-06-14	U-4534	Drug product	2026-06-05
N215866-002	12343382	2039-07-22	U-4229		2025-07-25
N215866-002	12343382	2039-07-22	U-4230		2025-07-25
N215866-002	12343382	2039-07-22	U-4231		2025-07-25
N215866-002	12343382	2039-07-22	U-4232		2025-07-25
N215866-002	12343382	2039-07-22	U-4400		2025-07-25
N215866-002	12343382	2039-07-22	U-4401		2025-07-25
N215866-002	12616740	2039-07-22	U-4500		2026-05-05
N215866-002	12616740	2039-07-22	U-4501		2026-05-05
N215866-002	12616740	2039-07-22	U-4502		2026-05-05
N215866-002	12295987	2041-12-30	U-4192		2025-06-11
N215866-002	12295987	2041-12-30	U-4193		2025-06-11
N215866-003	9474780	2036-05-13	U-4374	Drug substance, Drug product	2022-06-09
N215866-003	11357820	2039-06-14		Drug product	2022-06-30
N215866-003	12453755	2039-06-14	U-4375		2025-11-17
N215866-003	12453755	2039-06-14	U-4376		2025-11-17
N215866-003	12453755	2039-06-14	U-4377		2025-11-17
N215866-003	12453755	2039-06-14	U-4378		2025-11-17
N215866-003	12453755	2039-06-14	U-4379		2025-11-17
N215866-003	12453755	2039-06-14	U-4380		2025-11-17
N215866-003	12453755	2039-06-14	U-4381		2025-11-17
N215866-003	12453755	2039-06-14	U-4382		2025-11-17
N215866-003	12453755	2039-06-14	U-4383		2025-11-17
N215866-003	12453755	2039-06-14	U-4384		2025-11-17
N215866-003	12453755	2039-06-14	U-4385		2025-11-17
N215866-003	12453755	2039-06-14	U-4386		2025-11-17
N215866-003	12453756	2039-06-14		Drug product	2025-11-17
N215866-003	12629404	2039-06-14	U-4533	Drug product	2026-06-05
N215866-003	12629404	2039-06-14	U-4534	Drug product	2026-06-05
N215866-003	12343382	2039-07-22	U-4229		2025-07-25
N215866-003	12343382	2039-07-22	U-4230		2025-07-25
N215866-003	12343382	2039-07-22	U-4231		2025-07-25
N215866-003	12343382	2039-07-22	U-4232		2025-07-25
N215866-003	12343382	2039-07-22	U-4400		2025-07-25
N215866-003	12343382	2039-07-22	U-4401		2025-07-25
N215866-003	12616740	2039-07-22	U-4500		2026-05-05

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 42 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215866-001	NCE	2027-05-13
N215866-001	NPP	2028-12-19
N215866-002	NCE	2027-05-13
N215866-002	NPP	2028-12-19
N215866-003	NCE	2027-05-13
N215866-003	NPP	2028-12-19
N215866-004	NCE	2027-05-13
N215866-004	NPP	2028-12-19
N215866-005	NCE	2027-05-13
N215866-006	NCE	2027-05-13
N215866-007	NCE	2027-05-13
N215866-007	NPP	2028-12-19
N215866-008	NCE	2027-05-13
N215866-008	NPP	2028-12-19
N215866-009	NCE	2027-05-13
N215866-009	NPP	2028-12-19
N215866-010	NCE	2027-05-13
N215866-010	NPP	2028-12-19
N215866-011	NCE	2027-05-13
N215866-012	NCE	2027-05-13
N215866-013	NCE	2027-05-13
N215866-013	NPP	2028-12-19
N215866-014	NCE	2027-05-13
N215866-014	NPP	2028-12-19
N215866-015	NCE	2027-05-13
N215866-015	NPP	2028-12-19
N215866-016	NCE	2027-05-13
N215866-016	NPP	2028-12-19
N215866-017	NCE	2027-05-13
N215866-017	NPP	2028-12-19
N215866-018	NCE	2027-05-13
N215866-018	NPP	2028-12-19
N215866-019	NCE	2027-05-13
N215866-019	NPP	2028-12-19
N215866-020	NCE	2027-05-13
N215866-020	NPP	2028-12-19
N215866-021	NCE	2027-05-13
N215866-021	NPP	2028-12-19
N215866-022	NCE	2027-05-13
N215866-022	NPP	2028-12-19
N215866-023	NCE	2027-05-13
N215866-024	NCE	2027-05-13

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 9 · 348 observed 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	N215866-001	MOUNJARO (AUTOINJECTOR)	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	MOUNJARO (AUTOINJECTOR)	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-003	MOUNJARO (AUTOINJECTOR)	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-004	MOUNJARO (AUTOINJECTOR)	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-005	MOUNJARO (AUTOINJECTOR)	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-006	MOUNJARO (AUTOINJECTOR)	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-007	MOUNJARO	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-008	MOUNJARO	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-009	MOUNJARO	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-010	MOUNJARO	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-011	MOUNJARO	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-012	MOUNJARO	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-013	MOUNJARO	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-014	MOUNJARO	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-015	MOUNJARO	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-016	MOUNJARO	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-017	MOUNJARO	50MG/2.4ML (20.8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-018	MOUNJARO	60MG/2.4ML (25MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-019	MOUNJARO KWIKPEN	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-020	MOUNJARO KWIKPEN	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-021	MOUNJARO KWIKPEN	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-022	MOUNJARO KWIKPEN	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-023	MOUNJARO KWIKPEN	50MG/2.4ML (20.8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-024	MOUNJARO KWIKPEN	60MG/2.4ML (25MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215866-001	MOUNJARO (AUTOINJECTOR)	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	MOUNJARO (AUTOINJECTOR)	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-003	MOUNJARO (AUTOINJECTOR)	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-004	MOUNJARO (AUTOINJECTOR)	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-005	MOUNJARO (AUTOINJECTOR)	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-006	MOUNJARO (AUTOINJECTOR)	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-007	MOUNJARO	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-008	MOUNJARO	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-009	MOUNJARO	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-010	MOUNJARO	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-011	MOUNJARO	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-012	MOUNJARO	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-013	MOUNJARO	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-014	MOUNJARO	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-015	MOUNJARO	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-016	MOUNJARO	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`

Observed Orange Book patent history#

Patent history page 1 of 69 · 2,730 observed states.

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	N215866-001	9474780	2036-05-13	U-4374	Drug substance, Drug product	2022-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	11357820	2039-06-14		Drug product	2022-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453755	2039-06-14	U-4375		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453755	2039-06-14	U-4376		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453755	2039-06-14	U-4377		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453755	2039-06-14	U-4378		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453755	2039-06-14	U-4379		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453755	2039-06-14	U-4380		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453755	2039-06-14	U-4381		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453755	2039-06-14	U-4382		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453755	2039-06-14	U-4383		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453755	2039-06-14	U-4384		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453755	2039-06-14	U-4385		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453755	2039-06-14	U-4386		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12453756	2039-06-14		Drug product	2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12629404	2039-06-14	U-4533	Drug product	2026-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12629404	2039-06-14	U-4534	Drug product	2026-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12343382	2039-07-22	U-4401		2025-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12343382	2039-07-22	U-4229		2025-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12343382	2039-07-22	U-4230		2025-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12343382	2039-07-22	U-4231		2025-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12343382	2039-07-22	U-4232		2025-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12343382	2039-07-22	U-4400		2025-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12616740	2039-07-22	U-4500		2026-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12616740	2039-07-22	U-4501		2026-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12616740	2039-07-22	U-4502		2026-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12295987	2041-12-30	U-4192		2025-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	12295987	2041-12-30	U-4193		2025-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	9474780	2036-05-13	U-4374	Drug substance, Drug product	2022-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	11357820	2039-06-14		Drug product	2022-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	12453755	2039-06-14	U-4376		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	12453755	2039-06-14	U-4383		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	12453755	2039-06-14	U-4379		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	12453755	2039-06-14	U-4375		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	12453755	2039-06-14	U-4380		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	12453755	2039-06-14	U-4382		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	12453755	2039-06-14	U-4377		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	12453755	2039-06-14	U-4381		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	12453755	2039-06-14	U-4384		2025-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	12453755	2039-06-14	U-4385		2025-11-17	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 10 · 384 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N215866-001	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-001	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-002	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-003	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-003	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-004	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-004	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-005	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-006	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-007	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-007	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-008	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-008	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-009	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-009	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-010	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-010	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-011	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-012	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-013	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-013	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-014	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-014	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-015	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-015	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-016	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-016	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-017	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-017	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-018	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-018	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-019	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-019	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-020	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-020	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-021	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-021	NPP	2028-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-022	NCE	2027-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215866-022	NPP	2028-12-19	`84e616aacf4f…`

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: MOUNJARO
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIRZEPATIDE	10 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
OYN3CCI6QE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2601767	Internal RxNorm lookup
2601770	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
78aad975-4971-49fa-b4b0-6aa39f76d2e7	Available on FDA.report

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mounjaro	TIRZEPATIDE	Eli Lilly and Company	d2d7da5d-ad07-4228-955f-cf7e355c8cc0	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866
MOUNJARO	TIRZEPATIDE	A-S Medication Solutions	78b268b4-9215-44b4-b565-fcec315d027c	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866
MOUNJARO	TIRZEPATIDE	A-S Medication Solutions	c1ceb7ca-9976-4ac1-b45c-3975de8aac4c	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866
MOUNJARO	TIRZEPATIDE	A-S Medication Solutions	78aad975-4971-49fa-b4b0-6aa39f76d2e7	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866 ndc (product): 50090-8021
MOUNJARO	TIRZEPATIDE	A-S Medication Solutions	7dd5ae1d-2156-44c1-a2d0-4be1bc76420e	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866
MOUNJARO	TIRZEPATIDE	A-S Medication Solutions	f4edc99a-ecdb-4a68-bcb4-69fbba2190e8	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866
MOUNJARO	TIRZEPATIDE	A-S Medication Solutions	0818426a-53eb-4db7-9609-bbae1e7a3964	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OYN3CCI6QE	TIRZEPATIDE	2023788-19-2	TIRZEPATIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-8021-0	50090802100	4 SYRINGE in 1 CARTON (50090-8021-0) / .5 mL in 1 SYRINGE	4 syringe	2026-07-28	No	No	Current