Labetalol Hydrochloride

Product NDC
70518-4201
Requested package NDC
70518-4201-0
11-digit product format
705184201
Labeler code
70518
Product ID
70518-4201_3ff4f9b1-7aa2-e196-e063-6294a90ae2e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075215
Marketing category
ANDA
Marketing start
2024-10-02
Substance
LABETALOL
Active strength
100 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075215-001LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29
A075215-002LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29
A075215-003LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075215-001AB
A075215-002AB
A075215-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075215-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075215-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075215-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075215-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075215-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075215-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075215-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075215-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075215-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075215-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075215-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075215-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075215-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075215-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075215-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075215-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075215-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075215-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075215-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075215-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075215-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075215-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075215-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075215-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075215-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075215-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075215-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075215-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075215-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075215-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075215-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075215-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075215-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075215-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075215-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075215-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075215-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075215-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075215-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075215-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LABETALOL100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R5H8897N95Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e2e50571-d8c1-43e7-b90f-877ba1c35c9bAvailable 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
70518-4201-0Labetalol Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4201LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]3Current NDC, 1 package rows20241213_e2e50571-d8c1-43e7-b90f-877ba1c35c9b.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack3909ac9e-6818-4c5d-ad0e-52865a574b452026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack35e7bce0-d9ff-4f8b-95c5-218da2a2d9292026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepackf7f7fade-98a6-4741-bfb9-f1eb54ad45652026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack0db22a64-1863-4188-850b-273ea746e3272026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepackd8b69cc9-bdee-4e24-a3d8-d1887de5a17d2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack6f919513-500e-4a05-935e-b6fc1615368a2026-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEInnogenix, Inc.82fc2d64-0572-4a9b-94fc-f6eb8d930c542025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMethod Pharmaceuticals, LLC733d6e32-ac90-4796-bf25-9d5887c897a52025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack0dcd514d-bda8-484b-8cf1-f5656aaab9ce2025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack20c26652-52da-4eef-8486-f91eb30e9ff72025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEREMEDYREPACK INC.e2e50571-d8c1-43e7-b90f-877ba1c35c9b2025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
ndc (package): 70518-4201-0
ndc (product): 70518-4201
ndc11 (package): 70518420100
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutions5faacbcc-f88f-42f7-8702-791ee82c4d182025-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack64cd636d-8b48-4f29-b41d-4a048335793e2024-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOLMarlex Pharmaceuticals Inc28c91727-e5a8-48b3-a4df-d7bec8feda402024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack94abdd54-a8e2-4858-8183-6c5d04dbceb52024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack1fce27dd-90a6-45cf-9bd7-13147d3cc0d72024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack706a877b-c388-43e7-b083-518111b288b02024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack5a39bb96-4a60-49e8-859c-16bda0fe18e42024-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack143ae21e-c350-4c92-b318-7537f4e465962024-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896758labetalol HCl 100 MG Oral TabletPSNe2e50571-d8c1-43e7-b90f-877ba1c35c9b4
896758labetalol hydrochloride 100 MG Oral TabletSCDe2e50571-d8c1-43e7-b90f-877ba1c35c9b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4201-070518420100180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4201-0) 2024-10-02NoNoCurrent