NDC Code(s) : 0169-1834-11, 0169-1834-02, 0169-3004-01, 0169-3004-15, 0169-3004-12, 0169-3004-25
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:0169-1834
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:0169-1834-111 in 1 CARTON 07/01/1991
110 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:0169-1834-021 in 1 CARTON 07/01/1991
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 BLA019959 07/01/1991
Novolin Human Insulin INJECTION, SUSPENSION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0169-3004
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:0169-3004-155 in 1 CARTON 09/06/2019
1NDC:0169-3004-013 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0169-3004-255 in 1 CARTON 09/06/2019
2NDC:0169-3004-123 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 BLA019959 09/06/2019

LABELER - Novo Nordisk(622920320)

PRINCIPAL DISPLAY PANEL

NDC 0169-1834-11

Novolin® N

NPH (insulin isophane

human) injectable suspension

100 units/mL (U-100)

For subcutaneous use only

10 mL multiple-dose vial

Novo Nordisk®

Image of Novolin N vial carton

PRINCIPAL DISPLAY PANEL

NDC 0169-1834-02

Novolin® N

NPH (insulin isophane

human) injectable suspension

100 units/mL (U-100)

For subcutaneous use only

10 mL multiple-dose vial

ReliOn®

Image of Novolin N vial carton - ReliOn

PRINCIPAL DISPLAY PANEL

NDC 0169-3004-15

List 300415

Novolin ® N

FlexPen®

NPH

(insulin isophane 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 at room temperature

(up to 86°F (30°C) and discard after 28 days.

Dispense in this sealed carton.

Shake carefully before using.

See enclosed insert for proper technique.

N

novo nordisk®

Image of Novolin N FlexPen carton

PRINCIPAL DISPLAY PANEL

NDC 0169-3004-25

List 300425

Novolin ® N

FlexPen®

NPH

(insulin isophane 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 at room temperature

(up to 86°F (30°C) and discard after 28 days.

Dispense in this sealed carton.

Shake carefully before using.

See enclosed insert for proper technique.

N

ReliOn®

Image of Novolin N FlexPen carton - ReliOn