ProAir Digihaler

Product NDC: 59310-540
11-digit product format: 593100540
Labeler code: 59310
Product ID: 59310-540_47ecc130-3bcd-4d61-83da-4789610e042b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: POWDER, METERED
Route: RESPIRATORY (INHALATION)
Labeler: Teva Respiratory, LLC
Application: NDA205636
Marketing category: NDA
Marketing start: 2019-10-04
Marketing end: 0000-00-00
Substance: ALBUTEROL SULFATE
Active strength: 90 ug/1
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
26005090-31a1-441d-920b-db3101a55d53	Product name	3	20250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04b	Product name	3	20250218
0a278166-c8aa-41b6-b4a5-6ac332bde76a	Product name	1	20230718
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
36390b75-5438-47d3-af60-732a654e9025	Product name	2	20220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8	Product name	6	20210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14	Product name	2	20200220
3aa5a017-61e9-0c89-adef-13e7964d22f0	Product name	3	20171208
c3c27a99-b8bc-4955-841c-26555f58ee7e	Product name	1	20150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59310-540-20	ProAir Digihaler	200 in 1 INHALER	POWDER, METERED	200	26
59310-540-20	ProAir Digihaler	1 in 1 BOX	POWDER, METERED	1	26
59310-540-21	ProAir Digihaler	200 in 1 INHALER	POWDER, METERED	200	26
59310-540-21	ProAir Digihaler	1 in 1 BOX	POWDER, METERED	1	26

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59310-540	PROAIR DIGIHALER (ALBUTEROL SULFATE) POWDER, METERED PROAIR DIGIHALER (ALBUTEROL SULFATE) INHALANT [TEVA RESPIRATORY, LLC]	26	Legacy NDC, 4 package rows	20240515_667ce3ec-5217-4b10-b712-f3e54fbbf087.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
021SEF3731	ALBUTEROL SULFATE	51022-70-9	ALBUTEROL SULFATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2166796	albuterol 90 MCG /INHAL Dry Powder Inhaler with sensor, 200 Actuations	PSN	667ce3ec-5217-4b10-b712-f3e54fbbf087	26
2166797	ProAir digihaler 90 MCG /INHAL Dry Powder Inhaler, 200 Actuations	PSN	667ce3ec-5217-4b10-b712-f3e54fbbf087	26
2166797	Sensor 200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder Inhaler [ProAir]	SBD	667ce3ec-5217-4b10-b712-f3e54fbbf087	26
2166796	Sensor 200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder Inhaler	SCD	667ce3ec-5217-4b10-b712-f3e54fbbf087	26
2166796	albuterol 90 MCG /INHAL Dry Powder Inhaler with sensor, 200 Actuations	SY	667ce3ec-5217-4b10-b712-f3e54fbbf087	26
2166797	ProAir digihaler 90 MCG /INHAL Dry Powder Inhaler, 200 Actuations	SY	667ce3ec-5217-4b10-b712-f3e54fbbf087	26
2166797	Sensor 200 ACTUAT ProAir 0.09 MG/ACTUAT Dry Powder Inhaler	SY	667ce3ec-5217-4b10-b712-f3e54fbbf087	26

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59310-540-20	59310054020	1 INHALER in 1 BOX (59310-540-20) > 200 POWDER, METERED in 1 INHALER	1 inhaler	2019-10-04	0000-00-00	Yes	No	Current
59310-540-21	59310054021	200 in 1 INHALER						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ProAir Digihaler - Teva Respiratory, LLC	Teva Respiratory, LLC	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	26