LABETALOL HYDROCHLORIDE
- Product NDC
- 70518-3557
- Requested package NDC
- 70518-3557-0
- 11-digit product format
- 705183557
- Labeler code
- 70518
- Product ID
- 70518-3557_f0d49ffc-0bff-4ddd-e053-2a95a90ac59c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA211953
- Marketing category
- ANDA
- Marketing start
- 2022-10-17
- Marketing end
- 0000-00-00
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 200 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 package | package | 70518-3557 | 70518-3557-0 | 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 | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-3557 | 70518-3557-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-3557 | 70518-3557-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211953-001 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | |
| A211953-002 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | |
| A211953-003 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211953-001 | AB |
| A211953-002 | AB |
| A211953-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211953-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | 2021-08-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211953-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2021-08-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211953-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2021-08-18 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A211953-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211953-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211953-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211953-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211953-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211953-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211953-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211953-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211953-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211953-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211953-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211953-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211953-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211953-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211953-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211953-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211953-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211953-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211953-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211953-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211953-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211953-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211953-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211953-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211953-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211953-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211953-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211953-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211953-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211953-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A211953-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211953-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211953-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211953-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211953-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211953-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211953-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211953-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211953-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211953-001 | AB | 1 | 1e350fbaab3a… |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-3557 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 2 | Legacy NDC | 20240116_9c8b6c4d-04e8-41e0-819e-162790b25590.zip |
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 | ed2293f8-2b82-c3db-e053-2995a90ad46c | 2026-06-22 | Warnings, Adverse reactions | 211953 ANDA211953 |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | fffb7c59-ad92-4e74-850d-d94d42b7fdc9 | 2026-06-04 | Warnings, Adverse reactions | 211953 ANDA211953 |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 04f9dcdf-4023-48ee-9e7d-ca9366d9db72 | 2026-05-22 | Warnings, Adverse reactions | 211953 ANDA211953 |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | REMEDYREPACK INC. | ae5d7b3b-e444-48d3-9d85-9b07319f9374 | 2026-04-10 | Warnings, Adverse reactions | 211953 ANDA211953 |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | Advagen Pharma Ltd | 106a0959-5830-489f-ba60-afd4eb0fac36 | 2026-04-02 | Warnings, Adverse reactions | 211953 ANDA211953 |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | Advagen Pharma Ltd | 1c680447-b43a-4ff1-bc64-2c2174ca1c9a | 2026-04-02 | Warnings, Adverse reactions | 211953 ANDA211953 |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | Redpharm Drug | 32525ed4-3cca-2b99-e063-6294a90a6c66 | 2025-12-13 | Warnings, Adverse reactions | 211953 ANDA211953 |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | e6836a01-220d-4b69-9b4a-c919daeb6ece | 2025-11-20 | Warnings, Adverse reactions | 211953 ANDA211953 |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | 1a71964e-e6fa-443e-bfdd-f8852f8cf29e | 2023-10-26 | Warnings, Adverse reactions | 211953 ANDA211953 |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | c586ab65-56e8-4a4f-b471-902198d3e58c | 2023-10-17 | Warnings, Adverse reactions | 211953 ANDA211953 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-3557-0 | 70518355700 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3557-0) | 2022-10-17 | 0000-00-00 | No | No | Current |