Arformoterol Tartrate

Product NDC: 62756-277
11-digit product format: 627560277
Labeler code: 62756
Product ID: 62756-277_5314ef39-4fbf-4a1a-a101-efcc1e505fdf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Arformoterol Tartrate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA215385
Marketing category: ANDA
Marketing start: 2022-05-28
Substance: ARFORMOTEROL TARTRATE
Active strength: 15 ug/2mL
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], beta2-Adrenergic 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 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
A215385-001	ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN		2022-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A215385-001	AN

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215385-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215385-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215385-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215385-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215385-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215385-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215385-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215385-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215385-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215385-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215385-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215385-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215385-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215385-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215385-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215385-001	AN	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215385-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215385-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215385-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215385-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215385-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215385-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215385-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215385-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215385-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215385-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215385-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215385-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215385-001	AN	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215385-001	AN	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARFORMOTEROL TARTRATE	15 ug/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5P8VJ2I235	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
668956	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
f1005878-0c48-4b9a-843e-b6cf6b8bb251	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15e9fde8-93fa-6f6d-5bf2-f94be8a41a73	Product name	6	20260202

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62756-277-02	Arformoterol Tartrate	6 in 1 CARTON	SOLUTION	6	4
62756-277-02	Arformoterol Tartrate	5 in 1 POUCH	SOLUTION	5	4
62756-277-03	Arformoterol Tartrate	12 in 1 CARTON	SOLUTION	12	4
62756-277-03	Arformoterol Tartrate	5 in 1 POUCH	SOLUTION	5	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-277-02	ML - Milliliter	62756-277	f42da840-1ad2-43f0-a73c-b77260d5f48c	1	2022-07-06
62756-277-03	ML - Milliliter	62756-277	de466b24-ecec-4dd7-8dfd-3c07c9738db6	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-277	ARFORMOTEROL TARTRATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	3	Current NDC, Legacy NDC, 4 package rows	20220528_f1005878-0c48-4b9a-843e-b6cf6b8bb251.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arformoterol Tartrate	ARFORMOTEROL TARTRATE	Sun Pharmaceutical Industries, Inc.	f1005878-0c48-4b9a-843e-b6cf6b8bb251	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215385 application number: ANDA215385 ndc (product): 62756-277
Arformoterol Tartrate	ARFORMOTEROL TARTRATE	American Health Packaging	bb1a6643-f280-4f02-a824-0428a2b82d3c	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215385 application number: ANDA215385

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5P8VJ2I235	ARFORMOTEROL TARTRATE	200815-49-2	ARFORMOTEROL TARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
668956	arformoterol tartrate 15 MCG in 2 ML Inhalation Solution	PSN	f1005878-0c48-4b9a-843e-b6cf6b8bb251	4
668956	arformoterol 0.0075 MG/ML Inhalation Solution	SCD	f1005878-0c48-4b9a-843e-b6cf6b8bb251	4
668956	arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation Solution	SY	f1005878-0c48-4b9a-843e-b6cf6b8bb251	4
668956	arformoterol 15 MCG per 2 ML Inhalation Solution	SY	f1005878-0c48-4b9a-843e-b6cf6b8bb251	4
668956	arformoterol tartrate 15 MCG in 2 ML Inhalation Solution	PSN	bb1a6643-f280-4f02-a824-0428a2b82d3c	3
668956	arformoterol 0.0075 MG/ML Inhalation Solution	SCD	bb1a6643-f280-4f02-a824-0428a2b82d3c	3
668956	arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation Solution	SY	bb1a6643-f280-4f02-a824-0428a2b82d3c	3
668956	arformoterol 15 MCG per 2 ML Inhalation Solution	SY	bb1a6643-f280-4f02-a824-0428a2b82d3c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-277-02	62756027702	6 POUCH in 1 CARTON (62756-277-02) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE	6 pouch	2022-05-28	0000-00-00	No	No	Current
62756-277-03	62756027703	12 POUCH in 1 CARTON (62756-277-03) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE	12 pouch	2022-05-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Arformoterol Tartrate	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)	2026-04-14	Human Prescription Drug Label	4
Arformoterol Tartrate	American Health Packaging	2024-04-01	HUMAN PRESCRIPTION DRUG LABEL	3