Enoxaparin Sodium
- Product NDC
- 81952-128
- 11-digit product format
- 819520128
- Labeler code
- 81952
- Product ID
- 81952-128_48e2dcd3-c03e-580c-e063-6294a90aa4b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Enoxaparin Sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Hepalink USA Inc.
- Application
- ANDA205660
- Marketing category
- ANDA
- Marketing start
- 2023-03-15
- Substance
- ENOXAPARIN SODIUM
- Active strength
- 80 mg/.8mL
- Pharmacologic classes
- Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Enoxaparin Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ENOXAPARIN SODIUM | 80 mg/.8mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 8NZ41MIK1O |
| Rxcui | 854228, 854235, 854238, 854241, 854245, 854248, 854252 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 33a7d2c8-f5cf-4d97-8510-92190c5e0f12 | Product name | 7 | 20240606 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81952-128-18 | Enoxaparin Sodium | 0.8 mL in 1 SYRINGE | INJECTION, SOLUTION | 0.8 | 4 | |
| 81952-128-28 | Enoxaparin Sodium | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 81952-128-18 | ML - Milliliter | 81952-128 | 0e5a491e-0b6b-435c-b4c0-ea6ab76feb2c | 1 | 2023-06-06 |
| 81952-128-28 | ML - Milliliter | 81952-128 | 99bfd46c-f016-48a4-8943-d65d2f589220 | 1 | 2023-06-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 854248 | enoxaparin sodium 100 MG in 1 ML Prefilled Syringe | PSN | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854245 | enoxaparin sodium 120 MG in 0.8 ML Prefilled Syringe | PSN | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854252 | enoxaparin sodium 150 MG in 1 ML Prefilled Syringe | PSN | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854228 | enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe | PSN | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854235 | enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe | PSN | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854238 | enoxaparin sodium 60 MG in 0.6 ML Prefilled Syringe | PSN | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854241 | enoxaparin sodium 80 MG in 0.8 ML Prefilled Syringe | PSN | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854228 | 0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe | SCD | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854235 | 0.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe | SCD | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854238 | 0.6 ML enoxaparin sodium 100 MG/ML Prefilled Syringe | SCD | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854241 | 0.8 ML enoxaparin sodium 100 MG/ML Prefilled Syringe | SCD | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854245 | 0.8 ML enoxaparin sodium 150 MG/ML Prefilled Syringe | SCD | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854248 | 1 ML enoxaparin sodium 100 MG/ML Prefilled Syringe | SCD | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854252 | 1 ML enoxaparin sodium 150 MG/ML Prefilled Syringe | SCD | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854228 | 0.3 ML ENX sodium 100 MG/ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854235 | 0.4 ML ENX sodium 100 MG/ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854238 | 0.6 ML ENX sodium 100 MG/ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854241 | 0.8 ML ENX sodium 100 MG/ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854245 | 0.8 ML ENX sodium 150 MG/ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854248 | 1 ML ENX sodium 100 MG/ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854252 | 1 ML ENX sodium 150 MG/ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854252 | enoxaparin 150 MG per 1 ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854248 | enoxaparin sodium 100 MG per 1 ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854245 | enoxaparin sodium 120 MG per 0.8 ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854228 | enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854235 | enoxaparin sodium 40 MG per 0.4 ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854238 | enoxaparin sodium 60 MG per 0.6 ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
| 854241 | enoxaparin sodium 80 MG per 0.8 ML Prefilled Syringe | SY | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 81952-128-18 | 81952012818 | 0.8 mL in 1 SYRINGE | 0.8 ml | Historical | |||
| 81952-128-28 | 81952012828 | 10 SYRINGE in 1 CARTON (81952-128-28) / .8 mL in 1 SYRINGE (81952-128-18) | 10 syringe | 2023-04-27 | No | No | Historical |