FDA.reportPublic FDA data

Phenylephrine hydrochloride

Product NDC
69097-535
11-digit product format
690970535
Labeler code
69097
Product ID
69097-535_434a1620-1c01-426c-82a3-d70f841b241a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Cipla USA Inc.
Application
ANDA210333
Marketing category
ANDA
Marketing start
2018-06-01
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69097-535-962025-12-16C16284748780-19d75b9cf-cdb5-f424-e053-dadaa90a57ce4a403897-c688-469a-ba71-b5558eeffb26
69097-535-962020-01-31C16284748780-19d75b9cf-cdb5-f424-e053-dadaa90a57ce4a403897-c688-469a-ba71-b5558eeffb26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-535-35ML - Milliliter69097-535b723773f-4264-4a13-966a-14a4bd4a7ccc12018-06-11
69097-535-96ML - Milliliter69097-535581ea34f-77c0-4ef6-bb21-0c0ed15b402412018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-535PHENYLEPHRINE HYDROCHLORIDE INJECTION [CIPLA USA INC.]5Legacy NDC20181204_4a403897-c688-469a-ba71-b5558eeffb26.zip