Liraglutide
- Product NDC
- 14403-3400
- 11-digit product format
- 144033400
- Labeler code
- 14403
- Product ID
- 14403-3400_1a36a385-111a-f5a9-e063-6294a90a29a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Liraglutide
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)
- Application
- ANDA215503
- Marketing category
- ANDA
- Marketing start
- 2024-06-21
- Substance
- LIRAGLUTIDE
- Active strength
- 18 mg/3mL
- Pharmacologic classes
- GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Liraglutide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIRAGLUTIDE | 18 mg/3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 839I73S42A |
| Rxcui | 897122 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 14403-3400-1 | Liraglutide | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | | 4 |
| 14403-3400-2 | Liraglutide | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 4 |
| 14403-3400-1 | Liraglutide | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | | 3 |
| 14403-3400-3 | Liraglutide | 3 in 1 CARTON | INJECTION, SOLUTION | 3 | | 3 |
| 14403-3400-1 | Liraglutide | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14403-3400 | LIRAGLUTIDE INJECTION, SOLUTION [HYBIO PHARMACEUTICAL CO., LTD. (PINGSHAN FACTORY)] | 4 | Current NDC, 2 package rows | 20241225_1a372465-d56b-2b80-e063-6394a90a3304.zip |
| 14403-3400 | LIRAGLUTIDE INJECTION, SOLUTION [HYBIO PHARMACEUTICAL CO., LTD. (PINGSHAN FACTORY)] | 3 | Current NDC, 2 package rows | 20241225_1a36f43f-d734-97cc-e063-6294a90ae0da.zip |
| 14403-3400 | LIRAGLUTIDE INJECTION, SOLUTION [HYBIO PHARMACEUTICAL CO., LTD. (PINGSHAN FACTORY)] | 1 | Current NDC, 1 package rows | 20241224_1a36b801-41e2-2eed-e063-6294a90a6f27.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 14403-3400-1 | 14403340001 | 3 mL in 1 SYRINGE, PLASTIC (14403-3400-1) | 3 ml | 2024-06-21 | No | No | Historical |
| 14403-3400-2 | 14403340002 | 2 SYRINGE, PLASTIC in 1 CARTON (14403-3400-2) / 3 mL in 1 SYRINGE, PLASTIC (14403-3400-1) | | 2024-12-24 | No | No | Historical |
| 14403-3400-3 | 14403340003 | 3 SYRINGE, PLASTIC in 1 CARTON (14403-3400-3) / 3 mL in 1 SYRINGE, PLASTIC (14403-3400-1) | | 2024-12-24 | No | No | Historical |