Labetalol HCl in Dextrose
- Product NDC
- 0143-9366
- 11-digit product format
- 001439366
- Labeler code
- 0143
- Product ID
- 0143-9366_d0e3d92d-d96e-4d5e-98ca-3d18a4bc82d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA213330
- Marketing category
- NDA
- Marketing start
- 2020-11-09
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Labetalol HCl in Dextrose
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LABETALOL HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 2477889, 2479564, 2479566, 2479567 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| baf61d8c-dcd3-e95d-db84-9bb0d0a2b77f | Product name | 2 | 20220311 |
| 759f1c41-9262-4238-8cee-33988631aaf4 | Product name | 5 | 20220217 |
| 3b2edbb4-6acf-4674-b1d9-22addd3dad21 | Product name | 1 | 20210527 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9366-01 | Labetalol HCl in Dextrose | 200 mL in 1 BAG | INJECTION | 200 | 9 | |
| 0143-9366-10 | Labetalol HCl in Dextrose | 10 in 1 BOX | INJECTION | 10 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9366-01 | ML - Milliliter | 0143-9366 | dc2c5df0-e7bd-4967-b443-84f81a0ef799 | 1 | 2021-05-05 |
| 0143-9366-10 | ML - Milliliter | 0143-9366 | 5f5ff719-8e9d-42b4-9c51-854907e51578 | 1 | 2021-05-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0143-9366 | LABETALOL HCL IN SODIUM CHLORIDE (LABETALOL HYDROCHLORIDE) INJECTION LABETALOL HCL IN DEXTROSE (LABETALOL HYDROCHLORIDE) INJECTION LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250131_99a715a0-4579-410c-b102-7ef6fab8db55.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2477889 | labetalol HCl 20 MG in 4 ML Injection | PSN | 99a715a0-4579-410c-b102-7ef6fab8db55 | 9 |
| 2479566 | labetalol hydrochloride 100 MG in 100 ML Injection | PSN | 99a715a0-4579-410c-b102-7ef6fab8db55 | 9 |
| 2479564 | labetalol hydrochloride 200 MG in 200 ML Injection | PSN | 99a715a0-4579-410c-b102-7ef6fab8db55 | 9 |
| 2479567 | labetalol hydrochloride 300 MG in 300 ML Injection | PSN | 99a715a0-4579-410c-b102-7ef6fab8db55 | 9 |
| 2479566 | 100 ML labetalol hydrochloride 1 MG/ML Injection | SCD | 99a715a0-4579-410c-b102-7ef6fab8db55 | 9 |
| 2479564 | 200 ML labetalol hydrochloride 1 MG/ML Injection | SCD | 99a715a0-4579-410c-b102-7ef6fab8db55 | 9 |
| 2479567 | 300 ML labetalol hydrochloride 1 MG/ML Injection | SCD | 99a715a0-4579-410c-b102-7ef6fab8db55 | 9 |
| 2477889 | 4 ML labetalol hydrochloride 5 MG/ML Injection | SCD | 99a715a0-4579-410c-b102-7ef6fab8db55 | 9 |
| 2477889 | labetalol HCl 20 MG per 4 ML Injection | SY | 99a715a0-4579-410c-b102-7ef6fab8db55 | 9 |
| 2479566 | labetalol hydrochloride 100 MG per 100 ML Injection | SY | 99a715a0-4579-410c-b102-7ef6fab8db55 | 9 |
| 2479564 | labetalol hydrochloride 200 MG per 200 ML Injection | SY | 99a715a0-4579-410c-b102-7ef6fab8db55 | 9 |
| 2479567 | labetalol hydrochloride 300 MG per 300 ML Injection | SY | 99a715a0-4579-410c-b102-7ef6fab8db55 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0143-9366-01 | 00143936601 | 200 mL in 1 BAG | 200 ml | Historical | ||||
| 0143-9366-10 | 00143936610 | 10 BAG in 1 BOX (0143-9366-10) / 200 mL in 1 BAG (0143-9366-01) | 10 bag | 2020-11-09 | 0000-00-00 | No | No | Current |