NDC Code(s) : 0169-1837-11, 0169-1837-02, 0169-3007-01, 0169-3007-15, 0169-3007-12, 0169-3007-25
Packager : Novo Nordisk

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Novolin Human Insulin INJECTION, SUSPENSION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0169-1837
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN HUMAN(UNII: 1Y17CTI5SR)
(INSULIN HUMAN - UNII:1Y17CTI5SR) 		INSULIN HUMAN100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)
GLYCERIN(UNII: PDC6A3C0OX)
METACRESOL(UNII: GGO4Y809LO)
PHENOL(UNII: 339NCG44TV)
PROTAMINE SULFATE(UNII: 0DE9724IHC)
ZINC(UNII: J41CSQ7QDS)
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-1837-111 in 1 CARTON 25/06/1991
110 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:0169-1837-021 in 1 CARTON 25/06/1991
210 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA019991 06/25/1991
Novolin Human Insulin INJECTION, SUSPENSION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0169-3007
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN HUMAN(UNII: 1Y17CTI5SR)
(INSULIN HUMAN - UNII:1Y17CTI5SR) 		INSULIN HUMAN100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)
GLYCERIN(UNII: PDC6A3C0OX)
METACRESOL(UNII: GGO4Y809LO)
PHENOL(UNII: 339NCG44TV)
PROTAMINE SULFATE(UNII: 0DE9724IHC)
ZINC(UNII: J41CSQ7QDS)
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-3007-155 in 1 CARTON 06/01/2018
1NDC:0169-3007-013 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0169-3007-255 in 1 CARTON 06/01/2018
2NDC:0169-3007-123 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA019991 06/01/2018

LABELER - Novo Nordisk(622920320)

PRINCIPAL DISPLAY PANEL

NDC 0169-1837-11

Novolin®70/30

(insulin isophane human and

insulin human) injectable suspension

100 units/mL (U-100)

For subcutaneous use only

10 mL multiple-dose vial

Novo Nordisk®

Image of Novolin 70/30 vial carton

PRINCIPAL DISPLAY PANEL

NDC 0169-1837-02

Novolin®70/30

(insulin isophane human and

insulin human) injectable suspension

100 units/mL (U-100)

For subcutaneous use only

10 mL multiple-dose vial

ReliOn®

Image of Novolin 70/30 vial carton - ReliOn

PRINCIPAL DISPLAY PANEL

NDC 0169-3007-15

List: 300715

Novolin® 70/30

FlexPen®

(insulin isophane human and insulin human)

injectable suspension

For Single Patient Use Only

100 units/mL (U-100)

5×3 mL Prefilled Pens

For subcutaneous use only

Recommended for use with NovoFine®, NovoFine® Plus

or NovoTwist® disposable needles.

Store unopened pens refrigerated at 36°F to 46°F

(2°C to 8°C) in the original carton to protect from light

until expiration date or first use. Do not freeze.

After first use, store used pen at room temperature

(up to 86°F [30°C]), discard after 28 days.

Dispense in this sealed carton.

Shake carefully before using.

See enclosed insert for proper technique.

70/30

novo nordisk®

Image of Novolin 70/30 FlexPen carton

PRINCIPAL DISPLAY PANEL

NDC 0169-3007-25

List: 300725

Novolin® 70/30

FlexPen®

(insulin isophane human and insulin human)

injectable suspension

For Single Patient Use Only

100 units/mL (U-100)

5×3 mL Prefilled Pens

For subcutaneous use only

Recommended for use with NovoFine®, NovoFine® Plus

or NovoTwist® disposable needles.

Store unopened pens refrigerated at 36°F to 46°F

(2°C to 8°C) in the original carton to protect from light

until expiration date or first use. Do not freeze.

After first use, store used pen at room temperature

(up to 86°F [30°C]), discard after 28 days.

Dispense in this sealed carton.

Shake carefully before using.

See enclosed insert for proper technique.

70/30

ReliOn®

Image of Novolin 70/30 FlexPen carton - ReliOn