Labetalol Hydrochloride
- Product NDC
- 24979-168
- Requested package NDC
- 24979-168-01
- 11-digit product format
- 249790168
- Labeler code
- 24979
- Product ID
- 24979-168_03d305c1-fb1e-4c39-b743-157ae33343dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- TWi Pharmaceuticals, Inc.
- Application
- ANDA209603
- Marketing category
- ANDA
- Marketing start
- 2018-08-01
- Marketing end
- 0000-00-00
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 package | package | 24979-168 | 24979-168-01 | D | Discontinued by firm | 2026-08-17 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209603-001 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-20 | |
| A209603-002 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2018-06-20 | |
| A209603-003 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2018-06-20 | |
| A209603-004 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2024-10-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209603-001 | AB |
| A209603-002 | AB |
| A209603-003 | AB |
| A209603-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A209603-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209603-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2018-06-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209603-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2018-06-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209603-004 | LABETALOL HYDROCHLORIDE | 400MG | TABLET / ORAL | AB | 2024-10-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209603-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209603-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2018-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209603-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2018-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209603-004 | LABETALOL HYDROCHLORIDE | 400MG | TABLET / ORAL | 2024-10-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209603-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209603-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2018-06-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209603-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2018-06-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209603-004 | LABETALOL HYDROCHLORIDE | 400MG | TABLET / ORAL | 2024-10-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209603-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209603-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2018-06-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209603-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2018-06-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209603-004 | LABETALOL HYDROCHLORIDE | 400MG | TABLET / ORAL | 2024-10-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209603-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209603-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2018-06-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209603-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2018-06-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209603-004 | LABETALOL HYDROCHLORIDE | 400MG | TABLET / ORAL | 2024-10-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209603-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209603-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2018-06-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209603-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2018-06-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209603-004 | LABETALOL HYDROCHLORIDE | 400MG | TABLET / ORAL | 2024-10-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209603-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209603-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2018-06-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209603-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2018-06-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209603-004 | LABETALOL HYDROCHLORIDE | 400MG | TABLET / ORAL | 2024-10-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209603-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209603-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2018-06-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209603-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2018-06-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209603-004 | LABETALOL HYDROCHLORIDE | 400MG | TABLET / ORAL | 2024-10-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209603-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209603-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2018-06-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209603-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2018-06-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209603-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209603-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2018-06-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209603-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2018-06-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209603-004 | LABETALOL HYDROCHLORIDE | 400MG | TABLET / ORAL | 2024-10-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209603-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2018-06-20 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A209603-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209603-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209603-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209603-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209603-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209603-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209603-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209603-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209603-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209603-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209603-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209603-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209603-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209603-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209603-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209603-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209603-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209603-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209603-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209603-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209603-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209603-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209603-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209603-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209603-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209603-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209603-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209603-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209603-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209603-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209603-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209603-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209603-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209603-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209603-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209603-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209603-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209603-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209603-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209603-003 | AB | 1 | 301d65b070ca… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24979-168-01 | EA - Each | 24979-168 | 0a55d99f-009b-4802-bf17-abd7932e235d | 1 | 2018-10-11 |
| 24979-168-02 | EA - Each | 24979-168 | 9b91e9a5-ef3d-4fce-acf6-597987ed2eec | 1 | 2018-10-11 |
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 | St. Mary's Medical Park Pharmacy | 30281c4d-2fd1-167a-e063-6294a90a77c4 | 2026-06-30 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | REMEDYREPACK INC. | 5101b8dd-6148-465c-9bba-0209ce823fe5 | 2026-06-11 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Cardinal Health 107, LLC | d3ca153c-25b2-4506-91bd-bf9d6a4c01fe | 2026-05-19 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | c0c1a162-cd30-4ac9-bc62-407493ed54a5 | 2026-05-11 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Proficient Rx LP | 54b75509-824b-4291-818d-71dc1b88915f | 2026-05-01 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Golden State Medical Supply, Inc. | d5ce687f-4a37-d3e6-e053-2995a90aa974 | 2026-04-16 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | 371cb135-6a5f-433d-a87d-ab8521c4aa6d | 2026-04-16 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | f9af85d3-a5a7-49d6-aff6-1ca2b2d75450 | 2026-04-16 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | d4364caf-46c6-4144-9ba5-2c561e4f3a95 | 2026-03-26 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | d207396a-068e-4229-88cc-a1a4df7aeff2 | 2026-03-07 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | b4a5f170-a400-4986-8c64-f55d0413f0f6 | 2026-03-07 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Major Pharmaceuticals | 35b5fd32-581d-427b-9a13-b7a02846d21d | 2026-03-03 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Biocon Pharma Inc. | 27e4ab03-c17b-4268-912c-e45a5e8f8dd8 | 2026-02-19 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Northwind Health Company, LLC | faf7a1ff-f18a-8ca7-e053-6394a90a1b1f | 2026-01-01 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | dafa7411-2857-4f5a-a587-4367cfbe2bfa | 2025-10-23 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | RedPharm Drug | 1e1b7355-4802-d277-e063-6394a90aef44 | 2025-07-29 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | NuCare Pharmaceuticals , Inc. | 3aff731f-1eec-19b5-e063-6294a90a3143 | 2025-07-28 | Warnings, Adverse reactions | 209603 ANDA209603 |
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 30280d40-28df-4c88-93bd-357a7c528906 | 2024-06-21 | Warnings, Adverse reactions | 209603 ANDA209603 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 24979-168-01 | 24979016801 | 100 TABLET, FILM COATED in 1 BOTTLE (24979-168-01) | 2018-08-01 | 0000-00-00 | No | No | Current |