NDC 10885-003

Adasuve

Loxapine

Adasuve is a Respiratory (inhalation) Aerosol, Powder in the Human Prescription Drug category. It is labeled and distributed by Galen Us Incorporated. The primary component is Loxapine.

• Product ID: 10885-003_7c58079f-fd68-68de-e053-2a91aa0a137d
• NDC: 10885-003
• Product Type: Human Prescription Drug
• Proprietary Name: Adasuve
• Generic Name: Loxapine
• Dosage Form: Aerosol, Powder
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2017-09-26
• Marketing Category: NDA / NDA
• Application Number: NDA022549
• Labeler Name: Galen US Incorporated
• Substance Name: LOXAPINE
• Active Ingredient Strength: 10 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 10885-003-05

5 POUCH in 1 CARTON (10885-003-05) > 1 AEROSOL, POWDER in 1 POUCH (10885-003-01)

• Marketing Start Date: 2017-09-26
• Marketing End Date: 2021-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10885-003-05 [10885000305]

Adasuve AEROSOL, POWDER

• Marketing Category: NDA
• Application Number: NDA022549
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-26
• Marketing End Date: 2021-09-30

NDC 10885-003-01 [10885000301]

Adasuve AEROSOL, POWDER

• Marketing Category: NDA
• Application Number: NDA022549
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-26
• Marketing End Date: 2021-09-30

Drug Details

Active Ingredients

Ingredient	Strength
LOXAPINE	10 mg/1

OpenFDA Data

• SPL SET ID: 257148b5-869e-4a06-89ca-8b8686e8e528
• Manufacturer:
  • Galen US Incorporated
• UNII:
  • LER583670J
• RxNorm Concept Unique ID - RxCUI:
  • 1367518
  • 1367521

NDC Crossover Matching brand name "Adasuve" or generic name "Loxapine"

NDC	Brand Name	Generic Name
10885-003	Adasuve	loxapine
51097-001	Adasuve	loxapine
57844-510	Adasuve	Adasuve
0378-7005	Loxapine	loxapine
0378-7010	Loxapine	loxapine
0378-7025	Loxapine	loxapine
0378-7050	Loxapine	loxapine
0527-1394	Loxapine	Loxapine
0527-1395	Loxapine	Loxapine
0527-1396	Loxapine	Loxapine
0527-1397	Loxapine	Loxapine
0591-0369	Loxapine	Loxapine
0591-0370	Loxapine	Loxapine
0591-0371	Loxapine	Loxapine
0591-0372	Loxapine	Loxapine
17856-1397	Loxapine	Loxapine
35573-436	Loxapine	Loxapine
35573-437	Loxapine	Loxapine
35573-438	Loxapine	Loxapine
35573-439	Loxapine	Loxapine
50090-3099	Loxapine	Loxapine
50090-3457	Loxapine	loxapine
50090-4701	Loxapine	Loxapine
51079-901	Loxapine	loxapine
51079-902	Loxapine	loxapine
51079-903	Loxapine	loxapine