propranolol hydrochloride

Product NDC
55700-940
11-digit product format
557000940
Labeler code
55700
Product ID
55700-940_59b00ed0-766b-45d8-936f-eaa3846d2676
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA078703
Marketing category
ANDA
Marketing start
2021-09-10
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
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-940DDiscontinued by firm2026-08-07
excluded packagepackage55700-94055700-940-30DDiscontinued by firm2026-08-07

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 · 4 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 packagepackage55700-940-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-940-30f5e01cc5f278…a2eaf40c39c3…

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

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
A078703-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15
A078703-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15
A078703-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15
A078703-004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078703-001AB
A078703-002AB
A078703-003AB
A078703-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078703-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078703-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078703-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078703-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078703-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078703-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078703-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078703-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078703-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078703-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078703-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078703-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078703-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078703-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078703-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078703-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078703-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078703-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078703-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078703-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078703-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078703-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078703-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078703-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078703-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078703-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078703-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078703-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078703-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078703-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078703-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078703-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078703-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078703-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078703-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078703-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078703-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078703-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078703-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078703-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2011-07-15d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078703-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078703-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078703-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078703-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078703-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078703-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078703-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078703-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078703-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078703-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078703-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078703-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078703-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078703-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078703-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078703-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078703-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078703-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078703-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078703-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078703-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078703-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078703-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078703-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078703-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078703-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078703-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078703-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078703-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078703-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078703-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078703-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078703-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078703-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078703-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078703-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078703-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078703-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078703-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078703-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-940-30EA - Each55700-9407bb88b35-940a-484a-a12f-bec3f76523f312021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-940PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [QUALITY CARE PRODUCTS, LLC]3Legacy NDC20241220_5b94cfb7-5699-43a3-b4e2-1dbcdb549948.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack4803b5bf-8ca4-4a8b-bd24-1f3ff7d93d7e2026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDESt. Mary's Medical Park Pharmacy14957737-4e53-cc6d-e063-6294a90a181e2026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDESt. Mary's Medical Park Pharmacy36230aaa-b6e5-4ebb-e063-6294a90ac3b92026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEAvKARE753ab3cb-e7ee-424b-aa7d-195b5871a40e2026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.e0241448-5727-4c68-ae2a-6f41cd962d7c2026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack1aedd4d5-fe70-4cb0-9d6d-d2bd241ebaa62025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack96fa108c-b31c-445c-b978-c848cac594192025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack5cf8d0a4-4e02-48f0-8d1f-564357b250c52025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepacke0959293-321d-4427-8bb7-8e74b03464d62025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmerican Health Packaging015b5e4f-3228-4259-b419-e0e49694a0582025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack82a4d30b-5018-453d-a8ab-fef2e3266f692025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackc5ad5449-b93e-4f26-977b-c66466d8ac6f2025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.179e31a7-9956-4fba-9e9a-2ca28d37d42b2025-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack5ee3776f-9d02-4d98-bc9d-e810c87961c32024-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack0e185e88-cea2-4d01-8711-67317247fd252024-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack44a7900c-b240-4e04-954e-2671d4d51ae72024-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack8e675a00-2b20-4fcd-baa0-661bcf9809c82024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LP1d7c1de3-3cf4-4b1e-bdcc-55f423c880012024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutionsd1cfdb57-0b04-43f7-bd10-c585f77385b32023-08-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078703
application number: ANDA078703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-940-305570009403030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55700-940-30) 2021-09-100000-00-00NoNoCurrent