Labetalol HCL
- Product NDC
- 49884-122
- 11-digit product format
- 498840122
- Labeler code
- 49884
- Product ID
- 49884-122_c2fd5bf2-ce6b-48a7-a782-17dd1df2d326
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA200908
- Marketing category
- ANDA
- Marketing start
- 2012-07-24
- 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 product | product | 49884-122 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 49884-122 | 49884-122-01 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 49884-122 | 49884-122-05 | D | Discontinued by firm | 2026-08-10 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A200908-001 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | |
| A200908-002 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 |
| A200908-003 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200908-001 | AB |
| A200908-002 | AB |
| A200908-003 | 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 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200908-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | AB | RS | 2012-07-10 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200908-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2012-07-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A200908-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2012-07-10 | 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 | A200908-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200908-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200908-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200908-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200908-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200908-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200908-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200908-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200908-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200908-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200908-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200908-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200908-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200908-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200908-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200908-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200908-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200908-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200908-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200908-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200908-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200908-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200908-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200908-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200908-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200908-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200908-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200908-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200908-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200908-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200908-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200908-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200908-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200908-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200908-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200908-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200908-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200908-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200908-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A200908-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 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 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49884-122-01 | EA - Each | 49884-122 | bd4cebdf-7111-4219-9610-e9b1875d146d | 1 | 2013-02-13 |
| 49884-122-05 | EA - Each | 49884-122 | 3cef117a-22bb-477a-8a6d-33eac87bbe2f | 1 | 2013-11-04 |
DailyMed Socrata Ingredients#
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 HCL | LABETALOL HYDROCHLORIDE | A-S Medication Solutions | 312dde0d-5147-483e-968f-4e0d46114176 | 2025-06-19 | Warnings, Adverse reactions | 200908 ANDA200908 |
| Labetalol HCL | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | d80f884d-2092-4ddc-9e5a-5cce2974d61c | 2024-10-07 | Warnings, Adverse reactions | 200908 ANDA200908 |
| Labetalol HCL | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | 06ff81fe-9226-49a7-aa5c-f52b059d7cab | 2024-10-07 | Warnings, Adverse reactions | 200908 ANDA200908 |
| Labetalol HCL | LABETALOL HYDROCHLORIDE | Bryant Ranch Prepack | f1f28e7a-048c-436b-8901-7072ac1d81b7 | 2024-10-04 | Warnings, Adverse reactions | 200908 ANDA200908 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 896758 | labetalol HCl 100 MG Oral Tablet | PSN | f1f28e7a-048c-436b-8901-7072ac1d81b7 | 102 |
| 896758 | labetalol hydrochloride 100 MG Oral Tablet | SCD | f1f28e7a-048c-436b-8901-7072ac1d81b7 | 102 |
| 896758 | labetalol HCl 100 MG Oral Tablet | PSN | 312dde0d-5147-483e-968f-4e0d46114176 | 45 |
| 896762 | labetalol HCl 200 MG Oral Tablet | PSN | 312dde0d-5147-483e-968f-4e0d46114176 | 45 |
| 896766 | labetalol HCl 300 MG Oral Tablet | PSN | 312dde0d-5147-483e-968f-4e0d46114176 | 45 |
| 896758 | labetalol hydrochloride 100 MG Oral Tablet | SCD | 312dde0d-5147-483e-968f-4e0d46114176 | 45 |
| 896762 | labetalol hydrochloride 200 MG Oral Tablet | SCD | 312dde0d-5147-483e-968f-4e0d46114176 | 45 |
| 896766 | labetalol hydrochloride 300 MG Oral Tablet | SCD | 312dde0d-5147-483e-968f-4e0d46114176 | 45 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49884-122-01 | 49884012201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-122-01) | 2012-07-24 | 0000-00-00 | No | No | Current |
| 49884-122-05 | 49884012205 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-122-05) | 2012-07-24 | 0000-00-00 | No | No | Current |