Arformoterol tartrate

Product NDC: 62332-633
11-digit product format: 623320633
Labeler code: 62332
Product ID: 62332-633_10d5ad75-2475-42de-9acc-5c7fdd044bb6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Arformoterol tartrate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA214779
Marketing category: ANDA
Marketing start: 2022-05-10
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: 2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214779-001	ARFORMOTEROL TARTRATE	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN		2022-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214779-001	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
2026-08-18 06:07:40	2026-07	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214779-001	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	2022-05-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214779-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214779-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214779-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214779-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214779-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214779-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214779-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214779-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214779-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214779-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214779-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214779-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214779-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214779-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214779-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214779-001	AN	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214779-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214779-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214779-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214779-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214779-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214779-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214779-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214779-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214779-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214779-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214779-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214779-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214779-001	AN	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214779-001	AN	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Arformoterol tartrate
Listing expiration: 2026-12-31

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
f2feda53-54b9-4e40-8a01-9e7b45cb3d8c	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
62332-633-01	Arformoterol tartrate	01 in 1 POUCH	SOLUTION	01	10
62332-633-01	Arformoterol tartrate	2 mL in 1 VIAL	SOLUTION	2	10
62332-633-04	Arformoterol tartrate	4 in 1 POUCH	SOLUTION	4	10
62332-633-04	Arformoterol tartrate	2 mL in 1 VIAL	SOLUTION	2	10
62332-633-30	Arformoterol tartrate	30 in 1 CARTON	SOLUTION	30	10
62332-633-60	Arformoterol tartrate	60 in 1 CARTON	SOLUTION	60	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62332-633-01	ML - Milliliter	62332-633	23b2f18a-685d-4aef-81b6-a6dfe64d5964	1	2023-10-16
62332-633-04	ML - Milliliter	62332-633	617f80ed-f7f6-40bd-9448-4834d3c2904a	1	2023-10-16
62332-633-30	ML - Milliliter	62332-633	a2a9d968-47cf-4de5-b094-1d0eae4f95e9	1	2023-10-16
62332-633-60	ML - Milliliter	62332-633	8028c26a-d36f-452f-838b-54ca2dcf3546	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62332-633	ARFORMOTEROL TARTRATE SOLUTION [ALEMBIC PHARMACEUTICALS INC.]	9	Current NDC, Legacy NDC, 6 package rows	20240110_f2feda53-54b9-4e40-8a01-9e7b45cb3d8c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arformoterol tartrate	ARFORMOTEROL TARTRATE	Alembic Pharmaceuticals Inc.	f2feda53-54b9-4e40-8a01-9e7b45cb3d8c	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214779 application number: ANDA214779 ndc (product): 62332-633

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	f2feda53-54b9-4e40-8a01-9e7b45cb3d8c	10
668956	arformoterol 0.0075 MG/ML Inhalation Solution	SCD	f2feda53-54b9-4e40-8a01-9e7b45cb3d8c	10
668956	arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation Solution	SY	f2feda53-54b9-4e40-8a01-9e7b45cb3d8c	10
668956	arformoterol 15 MCG per 2 ML Inhalation Solution	SY	f2feda53-54b9-4e40-8a01-9e7b45cb3d8c	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62332-633-01	62332063301	01 in 1 POUCH						Historical
62332-633-04	62332063304	4 in 1 POUCH						Historical
62332-633-30	62332063330	30 POUCH in 1 CARTON (62332-633-30) / 1 VIAL in 1 POUCH (62332-633-01) / 2 mL in 1 VIAL	30 pouch	2022-05-10	0000-00-00	No	No	Current
62332-633-60	62332063360	60 POUCH in 1 CARTON (62332-633-60) / 4 VIAL in 1 POUCH (62332-633-04) / 2 mL in 1 VIAL	60 pouch	2022-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Arformoterol tartrate	Alembic Pharmaceuticals Inc. \| Rommelag CDMO GmbH	2025-12-22	Human Prescription Drug Label	10