MedPath

Erlotinib

Erlotinib Tablets

Approved
Approval ID

daaa1329-3a3f-439c-b13d-b301daa234d4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 17, 2020

Manufacturers
FDA

Cadila Healthcare Limited

DUNS: 918596198

Products 3

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

Erlotinib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70771-1522
Application NumberANDA213065
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2020
FDA Product Classification

INGREDIENTS (12)

ERLOTINIB HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT

Erlotinib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70771-1523
Application NumberANDA213065
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2020
FDA Product Classification

INGREDIENTS (12)

CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
ERLOTINIB HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

Erlotinib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70771-1521
Application NumberANDA213065
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2020
FDA Product Classification

INGREDIENTS (12)

ERLOTINIB HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT

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Erlotinib - FDA Drug Approval Details