Propranolol Hydrochloride

Product NDC
60687-926
11-digit product format
606870926
Labeler code
60687
Product ID
60687-926_4b1ce29b-201f-66c6-e063-6394a90a62cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078955
Marketing category
ANDA
Marketing start
2026-04-01
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
2027-12-31
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 · 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 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-02caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078955-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078955-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078955-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078955-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078955-005AB1caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Propranolol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE10 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856448Internal RxNorm lookup
856457Internal RxNorm lookup
856519Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c751ee54-27b4-4ed7-829a-ced735c41312Available 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
60687-926-01Propranolol Hydrochloride100 in 1 CARTONTABLET1001
60687-926-11Propranolol Hydrochloride1 in 1 BLISTER PACKTABLET11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-926-01EA - Each60687-926c8f1fe5d-d091-44dd-b631-81923229b4e712026-05-22
60687-926-11EA - Each60687-926871f9397-9996-407c-b920-2633a20ea04f12026-05-22

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
ndc (product): 60687-926
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSNc751ee54-27b4-4ed7-829a-ced735c413121
856448propranolol hydrochloride 10 MG Oral TabletSCDc751ee54-27b4-4ed7-829a-ced735c413121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-926-0160687092601100 BLISTER PACK in 1 CARTON (60687-926-01) / 1 TABLET in 1 BLISTER PACK (60687-926-11) 100 blister pack2026-04-01NoNoCurrent
60687-926-11606870926111 in 1 BLISTER PACKHistorical