AK-PENTOLATE
AK-PENTOLATE™ Cyclopentolate Hydrochloride Ophthalmic Solution, USP -Sterile
Approved
Approval ID
1d97ba11-5b69-4ba3-9310-fa000183de43
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cyclopentolate Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-883
Application NumberANDA040164
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclopentolate Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 9, 2009
FDA Product Classification
INGREDIENTS (8)
Cyclopentolate HydrochlorideActive
Quantity: 10 mg in 1 mL
Code: 736I6971TE
Classification: ACTIB
Benzalkonium ChlorideInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
Boric AcidInactive
Code: R57ZHV85D4
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Potassium ChlorideInactive
Code: 660YQ98I10
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium CarbonateInactive
Code: 45P3261C7T
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 3/9/2009
Akorn
Lake Forest, IL 60045
CP00N
Revised 05/08
Repackaged by:
Rebel Distributors Corp.
Thousand Oaks, CA 91320