Propranolol Hydrochloride

Product NDC
53808-0551
11-digit product format
538080551
Labeler code
53808
Product ID
53808-0551_951caa1a-b448-4864-abdc-4c47f87ef3cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA078955
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
20 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 productproduct53808-0551IInactivated by FDA2026-08-11
excluded packagepackage53808-055153808-0551-1IInactivated by FDA2026-08-11

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 packagepackage53808-0551-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0551-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0551-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0551-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0551-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0551-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0551-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0551-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0551-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0551-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0551-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0551-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0551-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0551-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0551-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0551-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0551-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0551-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0551-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0551-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0551-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53808-0551-1110d247fa046…a55b01930146…

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
A078955-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-02
A078955-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-02
A078955-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-02
A078955-004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-02
A078955-005PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078955-001AB
A078955-002AB
A078955-003AB
A078955-004AB
A078955-005AB

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 UTC2026-02A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2008-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2008-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2008-06-025bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078955-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078955-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078955-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078955-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078955-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078955-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078955-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078955-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078955-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078955-005AB15bbf6a4d5a75…

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
53808-0551-12019-10-21C16284748780-1956f9ecf-cd89-621f-e053-dbdaa90a74adPropranolol Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0551-1Propranolol Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0551PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100614_54a1bf1f-46e3-4940-93e4-5829d0ab6ec6.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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutions1bb6d65a-8264-4fa4-92d4-c4a756ec49ea2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmerican Health Packagingc751ee54-27b4-4ed7-829a-ced735c413122026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECardinal Health 107, LLC63abab85-ec88-4fcf-a8e7-0850e5f797ee2026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.554c7446-8407-460e-b157-f860c5afbf122026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC54154f18-2f15-d247-e063-6294a90a74122026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.2c9a6403-5ebf-4348-be02-7ffad58323692026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack4dd23053-0458-40f2-ac34-afb8cc9903aa2026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HCLPROPRANOLOL HCLDirect_Rx4ef5d75f-ca30-cd4a-e063-6394a90a8a432026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LPeac84d62-4824-48c7-a15e-0bfd897ab2f32026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackf70e5e97-a045-4d22-8da5-be4b7eb775302026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.9390cfd6-b2e0-48ad-8c4d-ed63cf6b923a2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.8bdb15bc-5a25-4f20-af98-79bcd26022b82026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack8f31a40c-7c79-457b-af6e-d945e4807cff2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECoupler LLC4a006e05-b8c3-236c-e063-6294a90abf262026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEIpca Laboratories Limited9288191e-4d07-4e37-ab66-7b9de9321cf32025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LPe289160e-0f3a-4667-b8ba-9c93fbf21a302025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutions62ef3d7d-c87f-4d2f-af12-47d50e8b54882025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutionsbe55cf2d-c2f8-4781-b2ef-fd607324265c2025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078955
application number: ANDA078955

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSN54a1bf1f-46e3-4940-93e4-5829d0ab6ec61
856457propranolol HCl 20 MG Oral TabletPSN54a1bf1f-46e3-4940-93e4-5829d0ab6ec61
856448propranolol hydrochloride 10 MG Oral TabletSCD54a1bf1f-46e3-4940-93e4-5829d0ab6ec61
856457propranolol hydrochloride 20 MG Oral TabletSCD54a1bf1f-46e3-4940-93e4-5829d0ab6ec61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0551-15380805510130 in 1 BLISTER PACKHistorical