PROPRANOLOL HYDROCHLORIDE

Product NDC
72189-018
11-digit product format
721890018
Labeler code
72189
Product ID
72189-018_8ed46816-31c5-3351-e053-2a95a90aa244
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPRANOLOL HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078703
Marketing category
ANDA
Marketing start
2019-07-29
Marketing end
0000-00-00
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
80 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72189-018IInactivated by FDA2026-08-03
excluded packagepackage72189-01872189-018-30IInactivated by FDA2026-08-03

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 · 30 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 packagepackage72189-018-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72189-018-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72189-018-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72189-018-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72189-018-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72189-018-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72189-018-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-018-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-018-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72189-018-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72189-018-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72189-018-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage72189-018-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage72189-018-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage72189-018-301332a3947898…d4bfe170f9cd…

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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-018-302023-01-30C16284748780-1f386c649-e3a8-0266-e053-dadaa90a7c1aPROPRANOLOL HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-018-30PROPRANOLOL HYDROCHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-018-30EA - Each72189-0181030cb12-e989-4af9-b410-79a12a40c0f712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-018PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20190730_8ed46816-31c4-3351-e053-2a95a90aa244.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN8ed46816-31c4-3351-e053-2a95a90aa2441
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD8ed46816-31c4-3351-e053-2a95a90aa2441
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY8ed46816-31c4-3351-e053-2a95a90aa2441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-018-307218900183030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-018-30) 2019-07-290000-00-00NoNoCurrent