Labetalol Hydrochloride
- Product NDC
- 0641-6252
- 11-digit product format
- 006416252
- Labeler code
- 0641
- Product ID
- 0641-6252_fa0062c6-f563-4d33-a540-fc2c7e91315d
- 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
- 2022-03-18
- Marketing end
- 0000-00-00
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0641-6252 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 0641-6252 | 0641-6252-10 | D | Discontinued by firm | 2026-10-05 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | LABETALOL HYDROCHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | |
| N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | LABETALOL HYDROCHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | |
| N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | LABETALOL HYDROCHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | |
| N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | LABETALOL HYDROCHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | |
| N213330-005 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | |
| N213330-006 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | b8a1b40f171c… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6252-10 | ML - Milliliter | 0641-6252 | 61759146-aa6e-4309-b5b7-85e61caef280 | 1 | 2023-04-07 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 99a715a0-4579-410c-b102-7ef6fab8db55 | 2025-12-19 | Warnings, Adverse reactions | 213330 NDA213330 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0641-6252-10 | 00641625210 | 10 SYRINGE, GLASS in 1 CARTON (0641-6252-10) > 2 mL in 1 SYRINGE, GLASS | 2022-03-18 | 0000-00-00 | No | No | Current |