Lantus
- Product NDC
- 55045-3685
- 11-digit product format
- 550453685
- Labeler code
- 55045
- Product ID
- 55045-3685_71907ed5-ee95-471a-8d7d-f72dcbbdfb60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin glargine
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Dispensing Solutions, Inc.
- Application
- NDA021081
- Marketing category
- NDA
- Marketing start
- 2009-09-23
- Marketing end
- 0000-00-00
- Substance
- INSULIN GLARGINE
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin [Chemical/Ingredient],Insulin Analog [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55045-3685-1 | Lantus | 10 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 10 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| insulin glargine | ACTIVE INGREDIENT | 2ZM8CX04RZ | LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| insulin glargine | ACTIVE MOIETY | 2ZM8CX04RZ | LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| METACRESOL | INACTIVE INGREDIENT | GGO4Y809LO | LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| zinc | INACTIVE INGREDIENT | J41CSQ7QDS | LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55045-3685 | LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 1 package rows | 20110930_f2149727-c2df-41b0-97f1-45ea75e0aa1a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 55045-3685-1 | 55045368501 | 10 mL in 1 VIAL, GLASS | 10 ml | Historical |