Propranolol hcl ER

Product NDC
61919-488
Requested package NDC
61919-488-30
11-digit product format
619190488
Labeler code
61919
Product ID
61919-488_86e7dadc-9f78-2e0f-e053-2991aa0a5ec8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol hcl ER
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Direct Rx
Application
NDA018553
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-10-23
Marketing end
0000-00-00
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
60 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.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-48861919-488-30IInactivated by FDA2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
N018553-001INDERAL LAPROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS1983-04-19
N018553-002INDERAL LAPROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-19
N018553-003INDERAL LAPROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-19
N018553-004INDERAL LAPROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALABRLD1987-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018553-001AB
N018553-002AB
N018553-003AB
N018553-004AB

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018553-001INDERAL LA160MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS1983-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07N018553-002INDERAL LA80MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07N018553-003INDERAL LA120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07N018553-004INDERAL LA60MGCAPSULE, EXTENDED RELEASE / ORALABRLD1987-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018553-001INDERAL LA160MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS1983-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018553-002INDERAL LA80MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018553-003INDERAL LA120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018553-004INDERAL LA60MGCAPSULE, EXTENDED RELEASE / ORALABRLD1987-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018553-001INDERAL LA160MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS1983-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018553-002INDERAL LA80MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018553-003INDERAL LA120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018553-004INDERAL LA60MGCAPSULE, EXTENDED RELEASE / ORALABRLD1987-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018553-001INDERAL LA160MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS1983-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018553-002INDERAL LA80MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018553-003INDERAL LA120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018553-004INDERAL LA60MGCAPSULE, EXTENDED RELEASE / ORALABRLD1987-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018553-001INDERAL LA160MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS1983-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018553-002INDERAL LA80MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018553-003INDERAL LA120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018553-004INDERAL LA60MGCAPSULE, EXTENDED RELEASE / ORALABRLD1987-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018553-001INDERAL LA160MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS1983-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018553-002INDERAL LA80MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018553-003INDERAL LA120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018553-004INDERAL LA60MGCAPSULE, EXTENDED RELEASE / ORALABRLD1987-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018553-001INDERAL LA160MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS1983-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018553-002INDERAL LA80MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018553-003INDERAL LA120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018553-004INDERAL LA60MGCAPSULE, EXTENDED RELEASE / ORALABRLD1987-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018553-001INDERAL LA160MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS1983-04-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018553-002INDERAL LA80MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018553-003INDERAL LA120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018553-004INDERAL LA60MGCAPSULE, EXTENDED RELEASE / ORALABRLD1987-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018553-001INDERAL LA160MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS1983-04-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018553-002INDERAL LA80MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018553-003INDERAL LA120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018553-004INDERAL LA60MGCAPSULE, EXTENDED RELEASE / ORALABRLD1987-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018553-001INDERAL LA160MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS1983-04-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018553-002INDERAL LA80MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018553-003INDERAL LA120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1983-04-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018553-004INDERAL LA60MGCAPSULE, EXTENDED RELEASE / ORALABRLD1987-03-18d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018553-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N018553-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N018553-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N018553-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018553-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018553-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018553-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018553-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018553-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018553-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018553-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018553-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018553-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018553-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018553-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018553-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018553-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018553-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018553-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018553-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018553-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018553-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018553-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018553-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018553-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018553-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018553-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018553-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018553-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018553-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018553-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018553-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018553-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018553-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018553-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018553-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018553-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018553-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018553-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018553-004AB1d8e5a09893c0…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-488-302025-01-31C16284748780-11030e365-1ab9-111a-e063-dadaa90a10e2Propranolol hcl ER 60mg
61919-488-302024-01-30C16284748780-11030e365-1ab9-111a-e063-dadaa90a10e2Propranolol hcl ER 60mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-488-30Propranolol hcl ER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-488-30EA - Each61919-4883a493158-c1bd-4ddf-93d9-1cacaa7b8db812017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-488PROPRANOLOL HCL ER CAPSULE, EXTENDED RELEASE PROPRANOLOL HYDROCHLORIDE ER CAPSULE, EXTENDED RELEASE PROPRANOLOL HCL ER CAPSULE, EXTENDED RELEASE [DIRECT RX]2Legacy NDC, 1 package rows20190420_5c370417-eff0-7280-e053-2a91aa0a1446.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
Propranolol Hydrochloride ERPROPRANOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.5415904b-90da-48e8-9f9e-f86749aa129c2024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018553
application number: NDA018553
INDERAL LAPROPRANOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.35d28979-36b1-4630-b85e-a44e0a4437342024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018553
application number: NDA018553

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN5c370417-eff0-7280-e053-2a91aa0a14462
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN5c370417-eff0-7280-e053-2a91aa0a14462
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD5c370417-eff0-7280-e053-2a91aa0a14462
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD5c370417-eff0-7280-e053-2a91aa0a14462
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY5c370417-eff0-7280-e053-2a91aa0a14462
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY5c370417-eff0-7280-e053-2a91aa0a14462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-488-306191904883030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (61919-488-30) 2017-10-230000-00-00NoNoCurrent