Labetalol Hydrochloride

Product NDC
0615-8513
11-digit product format
006158513
Labeler code
0615
Product ID
0615-8513_7af3cd76-a5ca-406d-9455-d442f8d658d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA209603
Marketing category
ANDA
Marketing start
2021-05-27
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
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Labetalol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LABETALOL HYDROCHLORIDE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1GEV3BAW9JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
896758Internal RxNorm lookup
896762Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30280d40-28df-4c88-93bd-357a7c528906Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf61d8c-dcd3-e95d-db84-9bb0d0a2b77fProduct name220220311
759f1c41-9262-4238-8cee-33988631aaf4Product name520220217
3b2edbb4-6acf-4674-b1d9-22addd3dad21Product name120210527

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8513-39Labetalol Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8513LABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]2Current NDC, 1 package rows20240622_30280d40-28df-4c88-93bd-357a7c528906.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
ndc (product): 0615-8513

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSN30280d40-28df-4c88-93bd-357a7c5289062
896762labetalol HCl 200 MG Oral TabletPSN30280d40-28df-4c88-93bd-357a7c5289062
896758labetalol hydrochloride 100 MG Oral TabletSCD30280d40-28df-4c88-93bd-357a7c5289062
896762labetalol hydrochloride 200 MG Oral TabletSCD30280d40-28df-4c88-93bd-357a7c5289062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8513-390061585133930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8513-39) 2024-06-18NoNoCurrent