Prescription Drug Information: ZOLPIMIST (Page 6 of 6)

Principal Display Panel — Zolpimist 30 Carton Label

NDC 69654-0510-30

Zolpi MISTâ„¢

(zolpidem tartrate) ORAL SPRAY

5 mg

per spray

30 metered sprays

Net Contents: 4.5 mL (4.8 g)

Spray Volume: 0.1 mL delivered per spray

CIV

Rx Only

Principal Display Panel -- Zolpimist 30 Carton Label
(click image for full-size original)

Principal Display Panel — Zolpimist 60 Carton Label

NDC 69654-0510-60

Zolpi MISTâ„¢

(zolpidem tartrate) ORAL SPRAY

5 mg

per spray

60 metered sprays

Net Contents: 7.7 mL (8.22 g)

Spray Volume: 0.1 mL delivered per spray

CIV

Rx Only

Principal Display Panel -- Zolpimist 60 Carton Label
(click image for full-size original)
ZOLPIMIST
zolpidem tartrate spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69654-510
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE (ZOLPIDEM) ZOLPIDEM TARTRATE 5 mg
Inactive Ingredients
Ingredient Name Strength
CHERRY
BENZOIC ACID
CITRIC ACID MONOHYDRATE
HYDROCHLORIC ACID
NEOTAME
PROPYLENE GLYCOL
WATER
Product Characteristics
Color Score
Shape Size
Flavor CHERRY (CHERRY) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69654-510-30 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
1 30 SPRAY, METERED in 1 BOTTLE, SPRAY This package is contained within the CARTON (69654-510-30)
2 NDC:69654-510-60 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
2 60 SPRAY, METERED in 1 BOTTLE, SPRAY This package is contained within the CARTON (69654-510-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022196 02/26/2019
Labeler — Aytu BioPharma, Inc. (828049556)
Registrant — Aytu BioPharma, Inc. (828049556)

Revised: 04/2021 Aytu BioPharma, Inc.

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