Labetalol Hydrochloride

Product NDC
63629-8901
11-digit product format
636298901
Labeler code
63629
Product ID
63629-8901_8e4a9735-053b-4bff-8bb6-0b3f75d90aad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209603
Marketing category
ANDA
Marketing start
2021-05-27
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-8901DDiscontinued by firm2026-08-17
excluded packagepackage63629-890163629-8901-1DDiscontinued by firm2026-08-17

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.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct63629-8901DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-890163629-8901-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209603-001LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2018-06-20
A209603-002LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2018-06-20
A209603-003LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2018-06-20
A209603-004LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE400MGTABLET / ORALAB2024-10-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A209603-001AB
A209603-002AB
A209603-003AB
A209603-004AB

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.

Product history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209603-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2018-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07A209603-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2018-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07A209603-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2018-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07A209603-004LABETALOL HYDROCHLORIDE400MGTABLET / ORALAB2024-10-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209603-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2018-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209603-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2018-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209603-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2018-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209603-004LABETALOL HYDROCHLORIDE400MGTABLET / ORAL2024-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209603-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2018-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209603-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2018-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209603-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2018-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209603-004LABETALOL HYDROCHLORIDE400MGTABLET / ORAL2024-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209603-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2018-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209603-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2018-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209603-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2018-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209603-004LABETALOL HYDROCHLORIDE400MGTABLET / ORAL2024-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209603-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2018-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209603-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2018-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209603-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2018-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209603-004LABETALOL HYDROCHLORIDE400MGTABLET / ORAL2024-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209603-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2018-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209603-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2018-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209603-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2018-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209603-004LABETALOL HYDROCHLORIDE400MGTABLET / ORAL2024-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209603-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2018-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209603-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2018-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209603-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2018-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209603-004LABETALOL HYDROCHLORIDE400MGTABLET / ORAL2024-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209603-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2018-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209603-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2018-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209603-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2018-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209603-004LABETALOL HYDROCHLORIDE400MGTABLET / ORAL2024-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209603-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2018-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209603-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2018-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209603-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2018-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209603-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2018-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209603-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2018-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209603-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2018-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209603-004LABETALOL HYDROCHLORIDE400MGTABLET / ORAL2024-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209603-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2018-06-20d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209603-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209603-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209603-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209603-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209603-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209603-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209603-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209603-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209603-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209603-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209603-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209603-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209603-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209603-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209603-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209603-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209603-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209603-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209603-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209603-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209603-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209603-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209603-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209603-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209603-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209603-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209603-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209603-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209603-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209603-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209603-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209603-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209603-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209603-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209603-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209603-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209603-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209603-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209603-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209603-003AB1301d65b070ca…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8901-1EA - Each63629-8901a97e1727-b746-45ac-873d-94e10b955b4912022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8901LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Legacy NDC20240113_1f8e0b6c-baeb-4942-b3f5-b4756b694e2d.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.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Labetalol HydrochlorideLABETALOL HYDROCHLORIDESt. Mary's Medical Park Pharmacy30281c4d-2fd1-167a-e063-6294a90a77c42026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEREMEDYREPACK INC.5101b8dd-6148-465c-9bba-0209ce823fe52026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECardinal Health 107, LLCd3ca153c-25b2-4506-91bd-bf9d6a4c01fe2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepackc0c1a162-cd30-4ac9-bc62-407493ed54a52026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEProficient Rx LP54b75509-824b-4291-818d-71dc1b88915f2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEGolden State Medical Supply, Inc.d5ce687f-4a37-d3e6-e053-2995a90aa9742026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutions371cb135-6a5f-433d-a87d-ab8521c4aa6d2026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsf9af85d3-a5a7-49d6-aff6-1ca2b2d754502026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsd4364caf-46c6-4144-9ba5-2c561e4f3a952026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsd207396a-068e-4229-88cc-a1a4df7aeff22026-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsb4a5f170-a400-4986-8c64-f55d0413f0f62026-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMajor Pharmaceuticals35b5fd32-581d-427b-9a13-b7a02846d21d2026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBiocon Pharma Inc.27e4ab03-c17b-4268-912c-e45a5e8f8dd82026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDENorthwind Health Company, LLCfaf7a1ff-f18a-8ca7-e053-6394a90a1b1f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepackdafa7411-2857-4f5a-a587-4367cfbe2bfa2025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDERedPharm Drug1e1b7355-4802-d277-e063-6394a90aef442025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDENuCare Pharmaceuticals , Inc.3aff731f-1eec-19b5-e063-6294a90a31432025-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603
Labetalol HydrochlorideLABETALOL HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs30280d40-28df-4c88-93bd-357a7c5289062024-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209603
application number: ANDA209603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8901-163629890101500 TABLET, FILM COATED in 1 BOTTLE (63629-8901-1) 2021-11-190000-00-00NoNoCurrent