Labetalol Hydrochloride
- Product NDC
- 63629-9283
- 11-digit product format
- 636299283
- Labeler code
- 63629
- Product ID
- 63629-9283_3efaa056-6e31-4b5f-9b6a-94e6620df647
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075215
- Marketing category
- ANDA
- Marketing start
- 2019-11-22
- Marketing end
- 0000-00-00
- Substance
- LABETALOL
- Active strength
- 300 mg/1
- 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 | 63629-9283 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 63629-9283 | 63629-9283-1 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-9283-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-9283-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-9283-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-9283-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-9283-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-9283-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63629-9283-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63629-9283-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63629-9283-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63629-9283-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63629-9283-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-9283-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075215-001 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | |
| A075215-002 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | |
| A075215-003 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075215-001 | AB |
| A075215-002 | AB |
| A075215-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075215-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 1999-07-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075215-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 1999-07-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075215-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 1999-07-29 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075215-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075215-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075215-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075215-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075215-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075215-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075215-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075215-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075215-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075215-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075215-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075215-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075215-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075215-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075215-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075215-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075215-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075215-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075215-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075215-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075215-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075215-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075215-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075215-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075215-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075215-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075215-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075215-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075215-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075215-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075215-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075215-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075215-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075215-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075215-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075215-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075215-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075215-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075215-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075215-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-9283-1 | EA - Each | 63629-9283 | 433805b9-1985-4c18-b17f-e2b3fdd736e6 | 1 | 2022-07-06 |
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 | Bryant Ranch Prepack | 3909ac9e-6818-4c5d-ad0e-52865a574b45 | 2026-03-25 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 35e7bce0-d9ff-4f8b-95c5-218da2a2d929 | 2026-03-25 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | f7f7fade-98a6-4741-bfb9-f1eb54ad4565 | 2026-03-25 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 0db22a64-1863-4188-850b-273ea746e327 | 2026-02-09 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | d8b69cc9-bdee-4e24-a3d8-d1887de5a17d | 2026-02-06 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 6f919513-500e-4a05-935e-b6fc1615368a | 2026-01-29 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Innogenix, Inc. | 82fc2d64-0572-4a9b-94fc-f6eb8d930c54 | 2025-12-23 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Method Pharmaceuticals, LLC | 733d6e32-ac90-4796-bf25-9d5887c897a5 | 2025-12-23 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 0dcd514d-bda8-484b-8cf1-f5656aaab9ce | 2025-10-29 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 20c26652-52da-4eef-8486-f91eb30e9ff7 | 2025-10-29 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | REMEDYREPACK INC. | e2e50571-d8c1-43e7-b90f-877ba1c35c9b | 2025-09-29 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | 5faacbcc-f88f-42f7-8702-791ee82c4d18 | 2025-01-09 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 64cd636d-8b48-4f29-b41d-4a048335793e | 2024-11-20 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL | Marlex Pharmaceuticals Inc | 28c91727-e5a8-48b3-a4df-d7bec8feda40 | 2024-10-07 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 94abdd54-a8e2-4858-8183-6c5d04dbceb5 | 2024-08-20 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 1fce27dd-90a6-45cf-9bd7-13147d3cc0d7 | 2024-08-12 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 706a877b-c388-43e7-b083-518111b288b0 | 2024-08-06 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 5a39bb96-4a60-49e8-859c-16bda0fe18e4 | 2024-06-05 | Warnings, Adverse reactions | 075215 ANDA075215 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 143ae21e-c350-4c92-b318-7537f4e46596 | 2024-04-08 | Warnings, Adverse reactions | 075215 ANDA075215 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-9283-1 | 63629928301 | 500 TABLET, FILM COATED in 1 BOTTLE (63629-9283-1) | 2022-06-06 | 0000-00-00 | No | No | Current |