Propranolol Hydrochloride

Product NDC
60760-545
11-digit product format
607600545
Labeler code
60760
Product ID
60760-545_c01fcaf6-a434-ec9a-e053-2995a90a0b65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA070322
Marketing category
ANDA
Marketing start
2021-04-08
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
20 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 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
A070322-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04
A070322-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22
A070322-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22
A070322-004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22
A070322-005PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070322-001AB
A070322-002AB
A070322-003AB
A070322-004AB
A070322-005AB

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 UTC2026-02A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-245bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 195 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070322-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070322-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-005AB15bbf6a4d5a75…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE20 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
856457Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c01fc93e-cff2-50d5-e053-2a95a90a1897Available 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
60760-545-60Propranolol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-545-60EA - Each60760-545f1e40a2a-1148-40fe-b82a-922f781a671b12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-545PROPRANOLOL HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, Legacy NDC, 1 package rows20210515_c01fc93e-cff2-50d5-e053-2a95a90a1897.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmerican Health Packagingd027f39e-7648-44c8-a8dc-b26b4cdd81be2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDESt. Mary's Medical Park Pharmacyc01fc93e-cff2-50d5-e053-2a95a90a18972026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
ndc (product): 60760-545
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.07c3fcab-33fe-4a6a-ba67-2d042190c1462026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4a2b8d97-b89b-6b68-e063-6394a90ab3322026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENorthwind Health Company, LLCc29d733a-4fcb-6564-e053-2995a90ae5412026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENorthwind Health Company, LLCda804f70-9558-6e85-e053-2a95a90a90792026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.f7ae2dac-6048-41ea-95d3-cad06cc2baf32025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackcd5cf31d-dade-425f-a32c-2e681a0087872025-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.52da1afc-7f1c-4893-ab84-8479dd9399512025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.582fe781-0759-4622-8fa6-b7d90e94e6962025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.86c48c5a-0a59-43a7-b3b5-41ab5da72ce12025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAsclemed USA, Inc.d08dbabc-8ca4-426e-a9fd-e7914a27883c2025-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.85973689-bb21-483f-becb-c5c8bfb056582025-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackfc1a2e79-3c3b-4e5a-8e75-0fd7abbac5a02025-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECardinal Health 107, LLC1df7f35e-b1d8-4aca-875e-d197cb61239e2025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEDirect Rxd7c0cc12-6d2d-7146-e053-2995a90a85a42025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC29ace768-8fef-482b-e063-6394a90aa2ac2024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.df61a348-0fe9-71c0-e053-2a95a90a9a4c2024-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackcf393c74-381f-4b60-8479-b0763bc71e8e2023-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LP91055555-6967-4b6a-b5c8-5211ec18d2c82023-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856457propranolol HCl 20 MG Oral TabletPSNc01fc93e-cff2-50d5-e053-2a95a90a18971
856457propranolol hydrochloride 20 MG Oral TabletSCDc01fc93e-cff2-50d5-e053-2a95a90a18971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-545-606076005456060 TABLET in 1 BOTTLE, PLASTIC (60760-545-60) 60 tablet2021-04-080000-00-00NoNoCurrent