ERMEZA

Product NDC: 49502-378
Requested package NDC: 49502-378-15
11-digit product format: 495020378
Labeler code: 49502
Product ID: 49502-378_97c0bb6f-0f8d-414d-88eb-a1590aeaeb9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levothyroxine sodium
Dosage form: SOLUTION
Route: ORAL
Labeler: Viatris Specialty LLC
Application: NDA215809
Marketing category: NDA
Marketing start: 2022-12-14
Marketing end: 2026-07-31
Substance: LEVOTHYROXINE SODIUM
Active strength: 30 ug/mL
Pharmacologic classes: Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49502-378	49502-378-15	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215809-001	ERMEZA	LEVOTHYROXINE SODIUM	150MCG/5ML	SOLUTION / ORAL		RLD, RS	2022-04-29

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215809-001	9345772	2035-02-27		Drug product	2022-05-13

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.

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	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
97c252d3-9bb8-4530-bb44-9824dc7cf556	Product name	6	20250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003	Product name	3	20240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8	Product name	5	20240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9f	Product name	5	20240207
01383843-4069-43cf-aa76-dc17a6f9f8c4	Product name	2	20230123
978cca7d-a938-4791-8322-da48d90a63ef	Product name	1	20230113
65f86ba3-8816-4e12-899b-18290c8de551	Product name	2	20210614
f16ab90f-08c2-40be-a543-66d9827cd1f3	Product name	1	20210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923	Product name	1	20190709
93355a10-1c44-4c92-a11d-7d995e0200d9	Product name	1	20190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49502-378-15	ERMEZA	150 mL in 1 BOTTLE, GLASS	SOLUTION	150	6
49502-378-15	ERMEZA	1 in 1 CARTON	SOLUTION	1	6
49502-378-75	ERMEZA	1 in 1 CARTON	SOLUTION	1	6
49502-378-75	ERMEZA	75 mL in 1 BOTTLE, GLASS	SOLUTION	75	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49502-378-15	ML - Milliliter	49502-378	11d7c7b1-d981-4fcb-8623-b8c317707754	1	2022-12-07
49502-378-75	ML - Milliliter	49502-378	7693b643-67bc-4b55-9e7c-e33e54c50e01	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49502-378	ERMEZA (LEVOTHYROXINE SODIUM) SOLUTION [VIATRIS SPECIALTY LLC]	5	Current NDC, Legacy NDC, 4 package rows	20250216_8ceeadb4-18be-46c7-9204-68b4edfbb96b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9J765S329G	LEVOTHYROXINE SODIUM	6106-07-6	LEVOTHYROXINE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2626056	Ermeza 150 MCG in 5 mL Oral Solution	PSN	8ceeadb4-18be-46c7-9204-68b4edfbb96b	6
2626050	levothyroxine sodium 150 MCG in 5 mL Oral Solution	PSN	8ceeadb4-18be-46c7-9204-68b4edfbb96b	6
2626056	levothyroxine sodium 0.03 MG/ML Oral Solution [Ermeza]	SBD	8ceeadb4-18be-46c7-9204-68b4edfbb96b	6
2626050	levothyroxine sodium 0.03 MG/ML Oral Solution	SCD	8ceeadb4-18be-46c7-9204-68b4edfbb96b	6
2626056	Ermeza 0.03 MG/ML Oral Solution	SY	8ceeadb4-18be-46c7-9204-68b4edfbb96b	6
2626056	Ermeza 150 MCG per 5 ML Oral Solution	SY	8ceeadb4-18be-46c7-9204-68b4edfbb96b	6
2626056	Ermeza 30 MCG per ML Oral Solution	SY	8ceeadb4-18be-46c7-9204-68b4edfbb96b	6
2626050	levothyroxine sodium 150 MCG per 5 ML Oral Solution	SY	8ceeadb4-18be-46c7-9204-68b4edfbb96b	6
2626050	levothyroxine sodium 30 MCG per ML Oral Solution	SY	8ceeadb4-18be-46c7-9204-68b4edfbb96b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49502-378-15	49502037815	1 BOTTLE, GLASS in 1 CARTON (49502-378-15) / 150 mL in 1 BOTTLE, GLASS	2022-12-14	2026-07-31	No	No	Current