Insulin Glargine Solostar

Product NDC: 50090-6178
11-digit product format: 500906178
Labeler code: 50090
Product ID: 50090-6178_34c1f3df-2dd5-4834-8643-9f772971c23f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: insulin glargine
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: A-S Medication Solutions
Application: BLA021081
Marketing category: BLA
Marketing start: 2022-05-02
Substance: INSULIN GLARGINE
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin Analog [EPC], Insulin [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Insulin Glargine Solostar
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	2ZM8CX04RZ
Rxcui	847230

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a9e2da77-dd6b-4b0e-9065-a13f87955fe1	Product name	1	20220720
5f5c996a-6aad-4f9a-86a2-e09dc8b634cb	Product name	1	20220207
1c45812e-8815-4d17-83e9-a18ac8df9bad	Product name	1	20210105
256d5b66-c6d0-4302-bcdf-00cf53e72c3b	Product name	2	20200323
2e66a9ce-feca-49d1-97e2-3bec86a60bd8	Product name	2	20200323
e43198b7-315b-480b-8517-8809d5ca232a	Product name	2	20200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6178-0	Insulin Glargine Solostar	5 in 1 CARTON	INJECTION, SOLUTION	5		3
50090-6178-0	Insulin Glargine Solostar	3 mL in 1 SYRINGE	INJECTION, SOLUTION	3		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6178-0	ML - Milliliter	50090-6178	723255f8-4acb-4a09-bd41-bcc6028f1790	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6178	INSULIN GLARGINE SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]	3	Current NDC, Legacy NDC, 2 package rows	20231102_9835904f-64f5-42b3-9ac9-89e4aaa5182a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
847230	insulin glargine 100 UNT/ML in 3 ML Pen Injector	PSN	9835904f-64f5-42b3-9ac9-89e4aaa5182a	3
847230	3 ML insulin glargine 100 UNT/ML Pen Injector	SCD	9835904f-64f5-42b3-9ac9-89e4aaa5182a	3
847230	3 ML insulin analog, glargine 100 UNT/ML Pen Injector	SY	9835904f-64f5-42b3-9ac9-89e4aaa5182a	3
847230	insulin analog, glargine 300 UNT Pen Injector	SY	9835904f-64f5-42b3-9ac9-89e4aaa5182a	3
847230	insulin glargine 300 UNT per 3 ML Pen Injector	SY	9835904f-64f5-42b3-9ac9-89e4aaa5182a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-6178-0	50090617800	5 SYRINGE in 1 CARTON (50090-6178-0) / 3 mL in 1 SYRINGE	5 syringe	2022-10-19	0000-00-00	No	No	Current