Propranolol Hydrochloride

Product NDC
17856-8728
11-digit product format
178568728
Labeler code
17856
Product ID
17856-8728_40333fbc-1ccd-7a2c-e063-6294a90a8bc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA070979
Marketing category
ANDA
Marketing start
1987-05-15
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
20 mg/5mL
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.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-153f01610625f2…
2019-09-15 20:21 UTC2019-09A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070979-001PROPRANOLOL HYDROCHLORIDE20MG/5MLSOLUTION / ORALRS1987-05-15cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Propranolol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE20 mg/5mL

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
856724Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
40333bee-749f-0b43-e063-6394a90a149cAvailable 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
17856-8728-1Propranolol Hydrochloride50 in 1 CASESOLUTION501
17856-8728-1Propranolol Hydrochloride5 mL in 1 CUPSOLUTION51

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.b609cc7c-1f6a-452b-8ada-c4d2989b83dc2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070979
application number: ANDA070979
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.40333bee-749f-0b43-e063-6394a90a149c2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070979
application number: ANDA070979
ndc (product): 17856-8728
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPharmaceutical Associates, Inc.ec5c919b-05d1-45d2-a6e4-ac4ae1101dbb2022-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070979
application number: ANDA070979

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856724propranolol HCl 20 MG in 5 mL Oral SolutionPSN40333bee-749f-0b43-e063-6394a90a149c1
856724propranolol hydrochloride 4 MG/ML Oral SolutionSCD40333bee-749f-0b43-e063-6394a90a149c1
856724propranolol hydrochloride 20 MG per 5 ML Oral SolutionSY40333bee-749f-0b43-e063-6394a90a149c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-8728-11785687280150 CUP in 1 CASE (17856-8728-1) / 5 mL in 1 CUP50 cup2025-10-01NoNoCurrent