Humulin

Product NDC: 0002-8315
11-digit product format: 000028315
Labeler code: 0002
Product ID: 0002-8315_79bc67f8-8bf8-4e92-bdd9-3e0700e6d9db
Type: HUMAN OTC DRUG
Nonproprietary name: Insulin human
Dosage form: INJECTION, SUSPENSION
Route: SUBCUTANEOUS
Labeler: Eli Lilly and Company
Application: BLA018781
Marketing category: BLA
Marketing start: 1983-06-27
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: Humulin
Brand name suffix: N
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	1Y17CTI5SR
Rxcui	311026, 311028, 847199, 1654862

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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	Strength	SPL version
0002-8315-01	Humulin N	1 in 1 CARTON	INJECTION, SUSPENSION	1		50
0002-8315-01	Humulin N	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SUSPENSION	10		50

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-8315-01	ML - Milliliter	0002-8315	8716a780-bbde-4b88-8b4c-df460a77286c	1	2012-07-24
0002-8315-17	ML - Milliliter	0002-8315	c1e99611-f679-4d5d-bfa5-b76f7c8b9134	1	2012-07-24
0002-8315-91	ML - Milliliter	0002-8315	7f3d225e-5b5f-44f5-9d2b-cc577fcb036e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INSULIN HUMAN	ACTIVE INGREDIENT	1Y17CTI5SR	HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
INSULIN HUMAN	ACTIVE MOIETY	1Y17CTI5SR	HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
PROTAMINE SULFATE	INACTIVE INGREDIENT	0DE9724IHC	HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
ZINC	INACTIVE INGREDIENT	J41CSQ7QDS	HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-8315	HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [ELI LILLY AND COMPANY]	47	Current NDC, Legacy NDC, 2 package rows	20240823_f6edd793-440b-40c2-96b5-c16133b7a921.zip

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
847199	HumuLIN N 100 UNT/ML in 3 ML Pen Injector	PSN	f6edd793-440b-40c2-96b5-c16133b7a921	50
311026	HumuLIN N 100 UNT/ML Injectable Suspension	PSN	f6edd793-440b-40c2-96b5-c16133b7a921	50
1654862	insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen Injector	PSN	f6edd793-440b-40c2-96b5-c16133b7a921	50
311028	insulin isophane (NPH), human 100 UNT/mL Injectable Suspension	PSN	f6edd793-440b-40c2-96b5-c16133b7a921	50
847199	3 ML insulin isophane, human 100 UNT/ML Pen Injector [Humulin N]	SBD	f6edd793-440b-40c2-96b5-c16133b7a921	50
311026	insulin isophane, human 100 UNT/ML Injectable Suspension [Humulin N]	SBD	f6edd793-440b-40c2-96b5-c16133b7a921	50
1654862	3 ML insulin isophane, human 100 UNT/ML Pen Injector	SCD	f6edd793-440b-40c2-96b5-c16133b7a921	50
311028	insulin isophane, human 100 UNT/ML Injectable Suspension	SCD	f6edd793-440b-40c2-96b5-c16133b7a921	50
847199	3 ML Humulin N 100 UNT/ML Pen Injector	SY	f6edd793-440b-40c2-96b5-c16133b7a921	50
847199	Humulin N (insulin isophane (NPH), human) 100 UNT/ML per 3 ML KwikPen	SY	f6edd793-440b-40c2-96b5-c16133b7a921	50
311026	Humulin N 100 UNT/ML Injectable Suspension	SY	f6edd793-440b-40c2-96b5-c16133b7a921	50
311028	insulin isophane (NPH), human 100 UNT/ML Injectable Suspension	SY	f6edd793-440b-40c2-96b5-c16133b7a921	50
1654862	insulin isophane (NPH), human 100 UNT/ML per 3 ML Pen Injector	SY	f6edd793-440b-40c2-96b5-c16133b7a921	50
1654862	insulin isophane U-100 per 3 ML Pen Injector	SY	f6edd793-440b-40c2-96b5-c16133b7a921	50
311026	HumuLIN N 100 UNT/ML Injectable Suspension	PSN	456e226e-e7b0-4850-b649-3d9e5533893c	12
311028	insulin isophane (NPH), human 100 UNT/mL Injectable Suspension	PSN	456e226e-e7b0-4850-b649-3d9e5533893c	12
311026	insulin isophane, human 100 UNT/ML Injectable Suspension [Humulin N]	SBD	456e226e-e7b0-4850-b649-3d9e5533893c	12
311028	insulin isophane, human 100 UNT/ML Injectable Suspension	SCD	456e226e-e7b0-4850-b649-3d9e5533893c	12
311026	Humulin N 100 UNT/ML Injectable Suspension	SY	456e226e-e7b0-4850-b649-3d9e5533893c	12
311028	insulin isophane (NPH), human 100 UNT/ML Injectable Suspension	SY	456e226e-e7b0-4850-b649-3d9e5533893c	12
311026	HumuLIN N 100 UNT/ML Injectable Suspension	PSN	81f28314-31c8-4114-a4b3-336eb2094558	1
311028	insulin isophane (NPH), human 100 UNT/mL Injectable Suspension	PSN	81f28314-31c8-4114-a4b3-336eb2094558	1
311026	insulin isophane, human 100 UNT/ML Injectable Suspension [Humulin N]	SBD	81f28314-31c8-4114-a4b3-336eb2094558	1
311028	insulin isophane, human 100 UNT/ML Injectable Suspension	SCD	81f28314-31c8-4114-a4b3-336eb2094558	1
311026	Humulin N 100 UNT/ML Injectable Suspension	SY	81f28314-31c8-4114-a4b3-336eb2094558	1
311028	insulin isophane (NPH), human 100 UNT/ML Injectable Suspension	SY	81f28314-31c8-4114-a4b3-336eb2094558	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0002-8315-01	00002831501	1 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-01) / 10 mL in 1 VIAL, MULTI-DOSE	1983-06-27	0000-00-00	No	No	Current
0002-8315-17	00002831517	1 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-17) > 3 mL in 1 VIAL, MULTI-DOSE	2010-06-24	0000-00-00	No	No	Current
0002-8315-99	00002831599	1 VIAL, MULTI-DOSE in 1 CARTON (0002-8315-99) > 10 mL in 1 VIAL, MULTI-DOSE	1983-06-27	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Humulin N	Eli Lilly and Company	2025-12-19	HUMAN OTC DRUG LABEL	50
Humulin N	A-S Medication Solutions	2017-10-11	HUMAN OTC DRUG LABEL	12
Humulin N - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-11-08	HUMAN OTC DRUG LABEL	1

Humulin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#