Inderal XL

Product NDC
62559-601
Requested package NDC
62559-601-77
11-digit product format
625590601
Labeler code
62559
Product ID
62559-601_63e1eabb-6c51-4088-bfa7-4a1cdcab4cef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA021438
Marketing category
NDA
Marketing start
2018-02-22
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021438-001INNOPRAN XLPROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-12
N021438-002INNOPRAN XLPROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021438-001BX
N021438-002BX

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-1284e616aacf4f…
2026-09-14 22:38:342026-08N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-1284e616aacf4f…
2026-08-18 06:07:402026-07N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-12caaa826d4ba7…
2026-08-18 06:07:402026-07N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021438-001INNOPRAN XL80MGCAPSULE, EXTENDED RELEASE / ORALBXRLD2003-03-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021438-002INNOPRAN XL120MGCAPSULE, EXTENDED RELEASE / ORALBXRLD, RS2003-03-1274a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021438-001BX184e616aacf4f…
2026-09-14 22:38:342026-08N021438-002BX184e616aacf4f…
2026-08-18 06:07:402026-07N021438-001BX1caaa826d4ba7…
2026-08-18 06:07:402026-07N021438-002BX1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021438-001BX1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021438-002BX1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021438-001BX131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021438-002BX131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021438-001BX16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021438-002BX16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021438-001BX1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021438-002BX1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021438-001BX1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021438-002BX1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021438-001BX103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021438-002BX103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021438-001BX12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021438-002BX12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021438-001BX15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021438-002BX15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021438-001BX1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021438-002BX1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021438-001BX1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021438-002BX1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021438-001BX179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021438-002BX179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021438-001BX1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021438-002BX1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021438-001BX11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021438-002BX11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021438-001BX18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021438-002BX18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021438-001BX15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021438-002BX15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021438-001BX15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021438-002BX15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021438-001BX14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021438-002BX14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021438-001BX174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021438-002BX174a2ff9319b5…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021438-00165004542021-10-04Drug product2003-03-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021438-00265004542021-10-04Drug product74a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021438-00165004542021-10-04Drug product2003-03-18782e0a99824c…
2021-12-28 21:50 UTC2021-12N021438-00265004542021-10-04Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021438-00165004542021-10-04Drug product2003-03-1887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021438-00265004542021-10-04Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N021438-00165004542021-10-04Drug product2003-03-185aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021438-00265004542021-10-04Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021438-00165004542021-10-04Drug product2003-03-188869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021438-00265004542021-10-04Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021438-00165004542021-10-04Drug product2003-03-18c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021438-00265004542021-10-04Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021438-00165004542021-10-04Drug product2003-03-183f01610625f2…
2019-12-14 00:12 UTC2019-12N021438-00265004542021-10-04Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021438-00165004542021-10-04Drug product2003-03-18b00525d2431f…
2019-09-15 20:21 UTC2019-09N021438-00265004542021-10-04Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021438-00165004542021-10-04Drug product2003-03-18ea99ee380514…
2019-07-19 19:46 UTC2019-07N021438-00265004542021-10-04Drug productea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Inderal XL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F8A3652H1VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856460Internal RxNorm lookup
856462Internal RxNorm lookup
856569Internal RxNorm lookup
856571Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac196ff5-9215-402b-bc57-69aa87f8badeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cfProduct name220200609
a5696e6c-a559-4d6b-bb53-f324106f317cProduct name120140718
0f446d3d-c9e6-1844-b8e8-a836dc35e0deProduct name120140508
33a4b7b4-a3c1-3f95-a202-01166dd77c44Product name120140508
60519d27-227d-404a-38bc-37524c8b386bProduct name120140508
d5f30598-8f94-b083-f161-65d67f2ae12aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-601-14Inderal XL14 in 1 BOTTLECAPSULE, EXTENDED RELEASE148
62559-601-30Inderal XL30 in 1 BOTTLECAPSULE, EXTENDED RELEASE308
62559-601-77Inderal XL7 in 1 BOTTLECAPSULE, EXTENDED RELEASE78

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-601-30EA - Each62559-601adaae300-b25b-47ab-b3a6-801fb149d51312018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-601INDERAL XL (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 3 package rows20240322_ac196ff5-9215-402b-bc57-69aa87f8bade.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Inderal XLPROPRANOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.ac196ff5-9215-402b-bc57-69aa87f8bade2026-08-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 021438
application number: NDA021438
ndc (package): 62559-601-77
ndc (product): 62559-601
ndc11 (package): 62559060177
InnoPran XLPROPRANOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.cd5601b3-4d87-4c3b-acac-b476e787609d2026-08-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 021438
application number: NDA021438

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856462Inderal LA 120 MG 24HR Extended Release Oral CapsulePSNac196ff5-9215-402b-bc57-69aa87f8bade8
856571Inderal LA 80 MG 24HR Extended Release Oral CapsulePSNac196ff5-9215-402b-bc57-69aa87f8bade8
856460propranolol HCl 120 MG 24HR Extended Release Oral CapsulePSNac196ff5-9215-402b-bc57-69aa87f8bade8
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSNac196ff5-9215-402b-bc57-69aa87f8bade8
85646224 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule [Inderal]SBDac196ff5-9215-402b-bc57-69aa87f8bade8
85657124 HR propranolol hydrochloride 80 MG Extended Release Oral Capsule [Inderal]SBDac196ff5-9215-402b-bc57-69aa87f8bade8
85646024 HR propranolol hydrochloride 120 MG Extended Release Oral CapsuleSCDac196ff5-9215-402b-bc57-69aa87f8bade8
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCDac196ff5-9215-402b-bc57-69aa87f8bade8
856462Inderal XL 120 MG 24 HR Extended Release Oral CapsuleSYac196ff5-9215-402b-bc57-69aa87f8bade8
856571Inderal XL 80 MG 24 HR Extended Release Oral CapsuleSYac196ff5-9215-402b-bc57-69aa87f8bade8
856460propranolol hydrochloride 120 MG 24 HR Extended Release Oral CapsuleSYac196ff5-9215-402b-bc57-69aa87f8bade8
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSYac196ff5-9215-402b-bc57-69aa87f8bade8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-601-77625590601777 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-77) 2018-02-220000-00-00NoNoCurrent