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Atropine Sulfate

These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION. ATROPINE SULFATE ophthalmic solution, for topical application to the eye.Initial U.S. Approval: 1960

Approved
Approval ID

b5f78b2a-56d1-4400-9d2f-b033cc13d26e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 11, 2024

Manufacturers
FDA

Lifestar Pharma LLC

DUNS: 080268943

Products 3

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

Atropine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70756-653
Application NumberANDA218148
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atropine Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 11, 2024
FDA Product Classification

INGREDIENTS (8)

ATROPINE SULFATEActive
Quantity: 10 mg in 1 mL
Code: 03J5ZE7KA5
Classification: ACTIB
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Atropine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70756-652
Application NumberANDA218148
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atropine Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 11, 2024
FDA Product Classification

INGREDIENTS (8)

ATROPINE SULFATEActive
Quantity: 10 mg in 1 mL
Code: 03J5ZE7KA5
Classification: ACTIB
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

Atropine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70756-651
Application NumberANDA218148
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atropine Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 11, 2024
FDA Product Classification

INGREDIENTS (8)

ATROPINE SULFATEActive
Quantity: 10 mg in 1 mL
Code: 03J5ZE7KA5
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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Atropine Sulfate - FDA Drug Approval Details