Humulin

Product NDC: 0002-0213
11-digit product format: 000020213
Labeler code: 0002
Product ID: 0002-0213_42527ae4-c593-4e13-8b77-c0511198c708
Type: HUMAN OTC DRUG
Nonproprietary name: Insulin human
Dosage form: INJECTION, SOLUTION
Route: PARENTERAL
Labeler: Eli Lilly and Company
Application: BLA018780
Marketing category: BLA
Marketing start: 1983-06-27
Marketing end: 2026-12-15
Substance: INSULIN HUMAN
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin [CS], Insulin [EPC]
NDC exclude flag: No
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Humulin
Brand name suffix: R

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311034	Internal RxNorm lookup
311036	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
b519bd83-038c-4ec5-a231-a51ec5cc291f	Available on FDA.report

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
0002-0213-01	Humulin R	3 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	3		34
0002-0213-01	Humulin R	1 in 1 CARTON	INJECTION, SOLUTION	1		34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-0213-01	ML - Milliliter	0002-0213	5dd9d547-b5aa-471e-b6ff-55073dfe869d	1	2023-12-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
insulin human	ACTIVE INGREDIENT	1Y17CTI5SR	HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]	22
insulin human	ACTIVE MOIETY	1Y17CTI5SR	HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]	22
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]	22
Hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]	22
Metacresol	INACTIVE INGREDIENT	GGO4Y809LO	HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]	22
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]	22
Water	INACTIVE INGREDIENT	059QF0KO0R	HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY ]	22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-0213	HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY]	33	Current NDC, 2 package rows	20230913_b519bd83-038c-4ec5-a231-a51ec5cc291f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Humulin R	INSULIN HUMAN	Eli Lilly and Company	b519bd83-038c-4ec5-a231-a51ec5cc291f	2025-05-27	Warnings, Adverse reactions	Exact identifier application number: BLA018780 ndc (product): 0002-0213
Humulin R U-500	INSULIN HUMAN	Eli Lilly and Company	b60e8dd0-1d48-4dc9-87fd-e14675255e8c	2024-02-22	Warnings, Adverse reactions	Exact identifier application number: BLA018780
HUMULIN R	INSULIN HUMAN	A-S Medication Solutions	81199e55-ade9-46de-a5a3-c0415acee403	2023-10-31	Warnings, Adverse reactions	Exact identifier application number: BLA018780

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
018780	Humulin R U-100	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
311036	HumuLIN R 100 UNT/ML Injectable Solution	PSN	b519bd83-038c-4ec5-a231-a51ec5cc291f	34
311034	regular insulin, human 100 UNT/ML Injectable Solution	PSN	b519bd83-038c-4ec5-a231-a51ec5cc291f	34
311036	insulin, regular, human 100 UNT/ML Injectable Solution [Humulin R]	SBD	b519bd83-038c-4ec5-a231-a51ec5cc291f	34
311034	insulin, regular, human 100 UNT/ML Injectable Solution	SCD	b519bd83-038c-4ec5-a231-a51ec5cc291f	34
311036	Humulin R 100 UNT/ML Injectable Solution	SY	b519bd83-038c-4ec5-a231-a51ec5cc291f	34
311034	insulin, human regular 100 UNT/ML Injectable Solution	SY	b519bd83-038c-4ec5-a231-a51ec5cc291f	34

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0002-0213-01	00002021301	1 VIAL, MULTI-DOSE in 1 CARTON (0002-0213-01) / 3 mL in 1 VIAL, MULTI-DOSE	2023-06-20	2026-12-15	No	No	Historical