Novolin

Product NDC: 0169-1837
11-digit product format: 001691837
Labeler code: 0169
Product ID: 0169-1837_c7164ea1-aa3e-4359-a3f0-a34c78e78398
Type: HUMAN OTC DRUG
Nonproprietary name: Human Insulin
Dosage form: INJECTION, SUSPENSION
Route: SUBCUTANEOUS
Labeler: Novo Nordisk
Application: BLA019991
Marketing category: BLA
Marketing start: 1991-06-25
Substance: INSULIN HUMAN
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin [CS], Insulin [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Novolin
Brand name suffix: 70/30
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INSULIN HUMAN	100 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1Y17CTI5SR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
213442	Internal RxNorm lookup
311048	Internal RxNorm lookup
847187	Internal RxNorm lookup
2049380	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
508a2763-3cb7-4be5-9e53-544e84cd9b1f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
d1997359-a049-4781-b04b-084a7f3cb039	Product name	2	20200325
aa12d3c0-d2b4-4c50-9af0-cb08b230ec20	Product name	2	20200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0169-1837-02	Novolin70/30	10 mL in 1 VIAL	INJECTION, SUSPENSION	10	18
0169-1837-02	Novolin70/30	1 in 1 CARTON	INJECTION, SUSPENSION	1	18
0169-1837-11	Novolin70/30	1 in 1 CARTON	INJECTION, SUSPENSION	1	18
0169-1837-11	Novolin70/30	10 mL in 1 VIAL	INJECTION, SUSPENSION	10	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0169-1837-02	ML - Milliliter	0169-1837	60a3b25e-a889-482d-b1b7-b570840838b5	1	2013-02-13
0169-1837-11	ML - Milliliter	0169-1837	2a96ef93-f20b-41f1-8528-3a8e1e8ff9b4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INSULIN HUMAN	ACTIVE INGREDIENT	1Y17CTI5SR	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]	9
INSULIN HUMAN	ACTIVE MOIETY	1Y17CTI5SR	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]	9
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]	9
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]	9
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]	9
PHENOL	INACTIVE INGREDIENT	339NCG44TV	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]	9
PROTAMINE SULFATE	INACTIVE INGREDIENT	0DE9724IHC	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]	9
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]	9
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]	9
ZINC CHLORIDE	INACTIVE INGREDIENT	86Q357L16B	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]	9
INSULIN HUMAN	ACTIVE INGREDIENT	1Y17CTI5SR	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]	2
INSULIN HUMAN	ACTIVE INGREDIENT	1Y17CTI5SR	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
INSULIN HUMAN	ACTIVE MOIETY	1Y17CTI5SR	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
INSULIN HUMAN	ACTIVE MOIETY	1Y17CTI5SR	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]	2
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]	2
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
PHENOL	INACTIVE INGREDIENT	339NCG44TV	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]	2
PHENOL	INACTIVE INGREDIENT	339NCG44TV	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
PROTAMINE SULFATE	INACTIVE INGREDIENT	0DE9724IHC	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]	2
PROTAMINE SULFATE	INACTIVE INGREDIENT	0DE9724IHC	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
ZINC CHLORIDE	INACTIVE INGREDIENT	86Q357L16B	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
ZINC CHLORIDE	INACTIVE INGREDIENT	86Q357L16B	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-1837	NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]	18	Current NDC, Legacy NDC, 4 package rows	20221208_508a2763-3cb7-4be5-9e53-544e84cd9b1f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Novolin 70/30	HUMAN INSULIN	A-S Medication Solutions	e825d7e9-467c-4f50-a6d6-f2602449c1de	2023-02-06	Warnings, Adverse reactions	Exact identifier application number: BLA019991
Novolin 70/30	HUMAN INSULIN	Novo Nordisk	508a2763-3cb7-4be5-9e53-544e84cd9b1f	2022-11-23	Warnings, Adverse reactions	Exact identifier application number: BLA019991 ndc (product): 0169-1837

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
019991	Novolin 70/30	insulin isophane human and insulin human	351(a)	OTC	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1Y17CTI5SR	INSULIN HUMAN	11061-68-0	INSULIN HUMAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
847187	insulin isophane, human 70 UNT/ML / insulin, human UNT/ML in 3 ML Pen Injector	PSN	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
311048	insulin, human isophane / insulin regular 70/30 Injectable Suspension	PSN	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
2049380	NovoLIN 70/30 in 3 ML Pen Injector	PSN	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
213442	NovoLIN 70/30 Injectable Suspension	PSN	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
2049380	3 ML insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Pen Injector [Novolin]	SBD	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
213442	insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Novolin]	SBD	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
847187	3 ML insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Pen Injector	SCD	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
311048	insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension	SCD	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
847187	insulin isophane, human 70 UNT/ML / insulin, human UNT/ML per 3 ML Pen Injector	SY	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
311048	insulin, human mixed 70/30 100 UNT/ML Injectable Suspension	SY	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
213442	Novolin 70/30 Injectable Suspension	SY	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
2049380	Novolin 70/30 per 3 ML Pen Injector	SY	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
213442	Relion Novolin 70/30 Injectable Suspension	SY	508a2763-3cb7-4be5-9e53-544e84cd9b1f	18
311048	insulin, human isophane / insulin regular 70/30 Injectable Suspension	PSN	e825d7e9-467c-4f50-a6d6-f2602449c1de	14
213442	NovoLIN 70/30 Injectable Suspension	PSN	e825d7e9-467c-4f50-a6d6-f2602449c1de	14
213442	insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Novolin]	SBD	e825d7e9-467c-4f50-a6d6-f2602449c1de	14
311048	insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension	SCD	e825d7e9-467c-4f50-a6d6-f2602449c1de	14
311048	insulin, human mixed 70/30 100 UNT/ML Injectable Suspension	SY	e825d7e9-467c-4f50-a6d6-f2602449c1de	14
213442	Novolin 70/30 Injectable Suspension	SY	e825d7e9-467c-4f50-a6d6-f2602449c1de	14
213442	Relion Novolin 70/30 Injectable Suspension	SY	e825d7e9-467c-4f50-a6d6-f2602449c1de	14
311048	insulin, human isophane / insulin regular 70/30 Injectable Suspension	PSN	8c7038f4-60d4-4604-814d-74921cdc1ad8	2
311048	insulin, human isophane / insulin regular 70/30 Injectable Suspension	PSN	0cc57309-01ef-4a02-8d27-b981c768135a	2
213442	NovoLIN 70/30 Injectable Suspension	PSN	8c7038f4-60d4-4604-814d-74921cdc1ad8	2
213442	NovoLIN 70/30 Injectable Suspension	PSN	0cc57309-01ef-4a02-8d27-b981c768135a	2
213442	insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Novolin]	SBD	8c7038f4-60d4-4604-814d-74921cdc1ad8	2
213442	insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Novolin]	SBD	0cc57309-01ef-4a02-8d27-b981c768135a	2
311048	insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension	SCD	8c7038f4-60d4-4604-814d-74921cdc1ad8	2
311048	insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension	SCD	0cc57309-01ef-4a02-8d27-b981c768135a	2
311048	insulin, human mixed 70/30 100 UNT/ML Injectable Suspension	SY	8c7038f4-60d4-4604-814d-74921cdc1ad8	2
311048	insulin, human mixed 70/30 100 UNT/ML Injectable Suspension	SY	0cc57309-01ef-4a02-8d27-b981c768135a	2
213442	Novolin 70/30 Injectable Suspension	SY	8c7038f4-60d4-4604-814d-74921cdc1ad8	2
213442	Novolin 70/30 Injectable Suspension	SY	0cc57309-01ef-4a02-8d27-b981c768135a	2
213442	Relion Novolin 70/30 Injectable Suspension	SY	0cc57309-01ef-4a02-8d27-b981c768135a	2
213442	Relion Novolin 70/30 Injectable Suspension	SY	8c7038f4-60d4-4604-814d-74921cdc1ad8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0169-1837-02	00169183702	1 VIAL in 1 CARTON (0169-1837-02) / 10 mL in 1 VIAL	1 vial	1991-06-25	0000-00-00	No	No	Current
0169-1837-11	00169183711	1 VIAL in 1 CARTON (0169-1837-11) / 10 mL in 1 VIAL	1 vial	1991-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Novolin 70/30	A-S Medication Solutions	2023-02-06	HUMAN OTC DRUG LABEL	14
Novolin 70/30	Novo Nordisk	2022-11-23	HUMAN OTC DRUG LABEL	18
Novolin 70/30, 70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection (recombinant DNA origin) ®	TYA Pharmaceuticals	2013-08-30	HUMAN OTC DRUG LABEL	2
Novolin ® 70/30, 70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection (recombinant DNA origin)	Physicians Total Care, Inc.	2012-01-11	HUMAN OTC DRUG LABEL	2