Propranolol Hydrochloride

Product NDC
53808-0772
11-digit product format
538080772
Labeler code
53808
Product ID
53808-0772_d6ad4be2-e6ec-4e44-8609-fd9ec50aacab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA070177
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct53808-0772IInactivated by FDA2026-08-17
excluded packagepackage53808-077253808-0772-1IInactivated by FDA2026-08-17

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 · 44 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 packagepackage53808-0772-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0772-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0772-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0772-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0772-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0772-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0772-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0772-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0772-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0772-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0772-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0772-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0772-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0772-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0772-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0772-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0772-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0772-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0772-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0772-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0772-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53808-0772-1110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070177-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070177-001AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-133f01610625f2…
2019-09-15 20:21 UTC2019-09A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070177-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-05-13e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A070177-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070177-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070177-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070177-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070177-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070177-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070177-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070177-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070177-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070177-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070177-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070177-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070177-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070177-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070177-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070177-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070177-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070177-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070177-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070177-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070177-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070177-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070177-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070177-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070177-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070177-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070177-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070177-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070177-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070177-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070177-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070177-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070177-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070177-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070177-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070177-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070177-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070177-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070177-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070177-001AB1e64feba35796…

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
53808-0772-12019-10-21C16284748780-1956f9ecf-bb5c-621f-e053-dbdaa90a74adPropranolol Hydrochoride Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0772-1Propranolol Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0772PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100614_0d5ac315-df2b-4b3a-bc7e-ad04752865c4.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.11873816-5789-e951-e063-6294a90ad16e2024-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070177
application number: ANDA070177

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856457propranolol HCl 20 MG Oral TabletPSN0d5ac315-df2b-4b3a-bc7e-ad04752865c41
856519propranolol HCl 40 MG Oral TabletPSN0d5ac315-df2b-4b3a-bc7e-ad04752865c41
856457propranolol hydrochloride 20 MG Oral TabletSCD0d5ac315-df2b-4b3a-bc7e-ad04752865c41
856519propranolol hydrochloride 40 MG Oral TabletSCD0d5ac315-df2b-4b3a-bc7e-ad04752865c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0772-15380807720130 in 1 BLISTER PACKHistorical