Midodrine Hydrochloride

Product NDC: 71335-2171
11-digit product format: 713352171
Labeler code: 71335
Product ID: 71335-2171_16f050fb-b3b9-4907-a67c-63642ff31f0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midodrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA212543
Marketing category: ANDA
Marketing start: 2019-08-19
Substance: MIDODRINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-2171_16f050fb-b3b9-4907-a67c-63642ff31f0e
SPL ID: 16f050fb-b3b9-4907-a67c-63642ff31f0e
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Midodrine Hydrochloride
Generic name: Midodrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Marketing start: 2019-08-19
Marketing category: ANDA
Application number: ANDA212543
Pharmacologic classes: Adrenergic alpha-Agonists [MoA]; alpha-Adrenergic Agonist [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
MIDODRINE HYDROCHLORIDE	5 mg/1

Package NDC	Description	Marketing start	Sample
71335-2171-1	30 TABLET in 1 BOTTLE (71335-2171-1)	2023-04-14	No

UNII	Preferred term	Registry number	Matched term
59JV96YTXV	MIDODRINE HYDROCHLORIDE	43218-56-0	MIDODRINE HYDROCHLORIDE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2171-1	71335217101	30 TABLET in 1 BOTTLE (71335-2171-1)	30 tablet	2023-04-14	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Midodrine Hydrochloride Tablets, USP	Bryant Ranch Prepack	2023-04-14	HUMAN PRESCRIPTION DRUG LABEL	100