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Bimatoprost

These highlights do not include all the information needed to use BIMATOPROST OPHTHALMIC SOLUTION0N, 0.03% safely and effectively. See full prescribing information for BIMATOPROST OPHTHALMIC SOLUTION, 0.03%. BIMATOPROST ophthalmic solution, 0.03% for topical ophthalmic use Initial U.S. Approval: 2001

Approved
Approval ID

2f9ee30a-1737-44b2-8479-79a3ee88bf5b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 9, 2022

Manufacturers
FDA

Fosun Pharma USA Inc.

DUNS: 080920998

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bimatoprost

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72266-140
Application NumberANDA210126
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bimatoprost
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (6)

BENZALKONIUM CHLORIDEInactive
Quantity: 0.05 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BIMATOPROSTActive
Quantity: 0.3 mg in 1 mL
Code: QXS94885MZ
Classification: ACTIB

Bimatoprost

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72266-241
Application NumberANDA210126
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bimatoprost
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (6)

CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BIMATOPROSTActive
Quantity: 0.3 mg in 1 mL
Code: QXS94885MZ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.05 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT

Bimatoprost

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72266-139
Application NumberANDA210126
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bimatoprost
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 9, 2022
FDA Product Classification

INGREDIENTS (6)

BENZALKONIUM CHLORIDEInactive
Quantity: 0.05 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BIMATOPROSTActive
Quantity: 0.3 mg in 1 mL
Code: QXS94885MZ
Classification: ACTIB

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Bimatoprost - FDA Drug Approval Details