Propranolol Hydrochloride

Product NDC
63187-839
11-digit product format
631870839
Labeler code
63187
Product ID
63187-839_a48795f5-fbef-445d-a633-8163755d6765
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078955
Marketing category
ANDA
Marketing start
2008-10-13
Marketing end
0000-00-00
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
10 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-839DDiscontinued by firm2026-08-11
excluded packagepackage63187-83963187-839-03DDiscontinued by firm2026-08-11
excluded packagepackage63187-83963187-839-30DDiscontinued by firm2026-08-11
excluded packagepackage63187-83963187-839-60DDiscontinued by firm2026-08-11
excluded packagepackage63187-83963187-839-90DDiscontinued by firm2026-08-11

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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-839-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-839-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-839-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-839-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-839-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-839-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-839-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-839-03f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078955-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-02
A078955-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-02
A078955-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-02
A078955-004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-02
A078955-005PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A078955-001AB
A078955-002AB
A078955-003AB
A078955-004AB
A078955-005AB

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-025bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078955-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078955-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-005AB15bbf6a4d5a75…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-839-03EA - Each63187-839929f6e0f-8887-4cea-b88a-625a6fa1e48b12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-839PROPRANOLOL HYDROCHLORIDE TABLET [PROFICIENT RX LP]3Legacy NDC20191113_a9d0b2dd-4407-47e1-adf3-830ddda0d491.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
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutions1bb6d65a-8264-4fa4-92d4-c4a756ec49ea2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmerican Health Packagingc751ee54-27b4-4ed7-829a-ced735c413122026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECardinal Health 107, LLC63abab85-ec88-4fcf-a8e7-0850e5f797ee2026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.554c7446-8407-460e-b157-f860c5afbf122026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC54154f18-2f15-d247-e063-6294a90a74122026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.2c9a6403-5ebf-4348-be02-7ffad58323692026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack4dd23053-0458-40f2-ac34-afb8cc9903aa2026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HCLPROPRANOLOL HCLDirect_Rx4ef5d75f-ca30-cd4a-e063-6394a90a8a432026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LPeac84d62-4824-48c7-a15e-0bfd897ab2f32026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackf70e5e97-a045-4d22-8da5-be4b7eb775302026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.9390cfd6-b2e0-48ad-8c4d-ed63cf6b923a2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.8bdb15bc-5a25-4f20-af98-79bcd26022b82026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack8f31a40c-7c79-457b-af6e-d945e4807cff2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECoupler LLC4a006e05-b8c3-236c-e063-6294a90abf262026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEIpca Laboratories Limited9288191e-4d07-4e37-ab66-7b9de9321cf32025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LPe289160e-0f3a-4667-b8ba-9c93fbf21a302025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutions62ef3d7d-c87f-4d2f-af12-47d50e8b54882025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutionsbe55cf2d-c2f8-4781-b2ef-fd607324265c2025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-839-03631870839033 TABLET in 1 BOTTLE (63187-839-03) 3 tablet2017-05-010000-00-00NoNoCurrent
63187-839-306318708393030 TABLET in 1 BOTTLE (63187-839-30) 30 tablet2017-05-010000-00-00NoNoCurrent
63187-839-606318708396060 TABLET in 1 BOTTLE (63187-839-60) 60 tablet2017-05-010000-00-00NoNoCurrent
63187-839-906318708399090 TABLET in 1 BOTTLE (63187-839-90) 90 tablet2017-05-010000-00-00NoNoCurrent