Propranolol Hydrochloride

Product NDC
71335-1765
11-digit product format
713351765
Labeler code
71335
Product ID
71335-1765_ebc207a3-62f9-4f11-a790-8caf04a30fea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212026
Marketing category
ANDA
Marketing start
2020-01-06
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
2026-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212026-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06
A212026-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06
A212026-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06
A212026-004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212026-001AB
A212026-002AB
A212026-003AB
A212026-004AB

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 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212026-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06caaa826d4ba7…
2026-08-18 06:07:402026-07A212026-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06caaa826d4ba7…
2026-08-18 06:07:402026-07A212026-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06caaa826d4ba7…
2026-08-18 06:07:402026-07A212026-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212026-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212026-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212026-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212026-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212026-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212026-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212026-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212026-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A212026-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212026-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212026-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212026-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212026-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212026-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212026-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212026-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212026-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212026-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212026-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212026-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212026-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212026-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212026-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212026-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212026-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212026-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212026-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212026-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212026-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212026-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212026-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212026-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212026-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212026-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212026-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212026-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2020-01-06d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212026-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212026-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212026-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212026-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212026-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212026-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212026-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212026-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212026-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212026-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212026-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212026-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212026-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212026-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212026-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212026-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212026-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212026-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212026-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212026-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212026-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212026-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212026-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212026-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212026-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212026-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212026-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212026-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212026-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212026-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212026-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212026-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212026-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212026-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212026-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212026-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212026-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212026-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212026-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212026-004AB1d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE60 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856535Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea98fedc-c440-487e-b144-35a8a389a446Available 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
71335-1765-1Propranolol Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30104
71335-1765-2Propranolol Hydrochloride18 in 1 BOTTLECAPSULE, EXTENDED RELEASE18104
71335-1765-3Propranolol Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE90104
71335-1765-4Propranolol Hydrochloride28 in 1 BOTTLECAPSULE, EXTENDED RELEASE28104
71335-1765-5Propranolol Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE60104
71335-1765-6Propranolol Hydrochloride10 in 1 BOTTLECAPSULE, EXTENDED RELEASE10104
71335-1765-7Propranolol Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1765PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 7 package rows20240915_ea98fedc-c440-487e-b144-35a8a389a446.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.414c4b69-38a1-4220-bec8-204c9a624b852026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212026
application number: ANDA212026
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutions87967c3a-4a6e-45c8-ae3d-1e1dbaa4ba102024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212026
application number: ANDA212026
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackea98fedc-c440-487e-b144-35a8a389a4462024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212026
application number: ANDA212026
ndc (product): 71335-1765
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackb9d12ace-7e30-4183-99a4-c0a5a6a55cdf2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212026
application number: ANDA212026
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDELannett Company, Inc.5229b561-287b-463c-8679-cda4c34f440b2024-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212026
application number: ANDA212026

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSNea98fedc-c440-487e-b144-35a8a389a446104
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCDea98fedc-c440-487e-b144-35a8a389a446104
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSYea98fedc-c440-487e-b144-35a8a389a446104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1765-17133517650130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-1) 2021-01-080000-00-00NoNoCurrent
71335-1765-27133517650218 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-2) 2024-09-060000-00-00NoNoCurrent
71335-1765-37133517650390 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-3) 2024-09-060000-00-00NoNoCurrent
71335-1765-47133517650428 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-4) 2024-09-060000-00-00NoNoCurrent
71335-1765-57133517650560 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-5) 2024-09-06NoNoCurrent
71335-1765-67133517650610 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-6) 2024-09-06NoNoCurrent
71335-1765-771335176507100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-7) 2024-09-06NoNoCurrent