Trandate
- Product NDC
- 65483-393
- 11-digit product format
- 654830393
- Labeler code
- 65483
- Product ID
- 65483-393_8d2825c1-c676-4a48-bb9f-e0e2b7cc9ee1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- labetalol hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Prometheus Laboratories Inc.
- Application
- NDA018716
- Marketing category
- NDA
- Marketing start
- 1984-05-31
- Marketing end
- 0000-00-00
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65483-393-10 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d8ef-8e05-e053-dbdaa90a074a | TRANDATE ® (labetalol hydrochloride) Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65483-393-10 | Trandate | 100 in 1 BOTTLE | TABLET | 100 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65483-393-10 | EA - Each | 65483-393 | 530b288c-1ae2-4a01-9e08-3126b22357c6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 896758 | labetalol HCl 100 MG Oral Tablet | PSN | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896762 | labetalol HCl 200 MG Oral Tablet | PSN | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896766 | labetalol HCl 300 MG Oral Tablet | PSN | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896777 | Trandate 100 MG Oral Tablet | PSN | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896781 | Trandate 200 MG Oral Tablet | PSN | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896783 | Trandate 300 MG Oral Tablet | PSN | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896777 | labetalol hydrochloride 100 MG Oral Tablet [Trandate] | SBD | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896781 | labetalol hydrochloride 200 MG Oral Tablet [Trandate] | SBD | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896783 | labetalol hydrochloride 300 MG Oral Tablet [Trandate] | SBD | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896758 | labetalol hydrochloride 100 MG Oral Tablet | SCD | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896762 | labetalol hydrochloride 200 MG Oral Tablet | SCD | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896766 | labetalol hydrochloride 300 MG Oral Tablet | SCD | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896777 | Trandate 100 MG Oral Tablet | SY | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896781 | Trandate 200 MG Oral Tablet | SY | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
| 896783 | Trandate 300 MG Oral Tablet | SY | a4195473-51a9-40f1-8678-1478ebca2d84 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 65483-393-10 | 65483039310 | 100 in 1 BOTTLE | Historical |