PROPRANOLOL HYDROCHLORIDE

Product NDC
51662-1338
11-digit product format
516621338
Labeler code
51662
Product ID
51662-1338_37b5006f-2441-f90b-e063-6294a90abb12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPRANOLOL HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA077760
Marketing category
ANDA
Marketing start
2018-12-22
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
1 mg/mL
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 · 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
A077760-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077760-001AP

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 06:07:402026-07A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS2008-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS2008-01-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS2008-01-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS2008-01-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS2008-01-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS2008-01-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS2008-01-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS2008-01-313f01610625f2…
2019-09-15 20:21 UTC2019-09A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS2008-01-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS2008-01-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077760-001PROPRANOLOL HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS2008-01-31e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077760-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077760-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077760-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077760-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077760-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077760-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077760-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077760-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077760-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077760-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077760-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077760-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077760-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077760-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077760-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077760-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077760-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077760-001AP14b0b4de00fa7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077760-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077760-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077760-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077760-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077760-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077760-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077760-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077760-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077760-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077760-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077760-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077760-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077760-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077760-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
PROPRANOLOL HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE1 mg/mL

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
856443Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7da73cee-4e98-462d-e053-2991aa0a8bf4Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1338-1PROPRANOLOL HYDROCHLORIDE1 mL in 1 VIALINJECTION18
51662-1338-2PROPRANOLOL HYDROCHLORIDE1 in 1 POUCHINJECTION18
51662-1338-2PROPRANOLOL HYDROCHLORIDE1 mL in 1 VIALINJECTION18
51662-1338-3PROPRANOLOL HYDROCHLORIDE10 in 1 CASEINJECTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1338PROPRANOLOL HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]7Current NDC, Legacy NDC, 4 package rows20240517_7da73cee-4e98-462d-e053-2991aa0a8bf4.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.91f2ff1d-68d8-4e83-a2db-618f0410ead72026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077760
application number: ANDA077760
PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst7da73cee-4e98-462d-e053-2991aa0a8bf42025-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077760
application number: ANDA077760
ndc (product): 51662-1338
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEMedical Purchasing Solutions, LLC693569bd-6053-5b3e-e053-2a91aa0a6e9c2023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077760
application number: ANDA077760

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856443propranolol HCl 1 MG in 1 ML InjectionPSN7da73cee-4e98-462d-e053-2991aa0a8bf48
8564431 ML propranolol hydrochloride 1 MG/ML InjectionSCD7da73cee-4e98-462d-e053-2991aa0a8bf48
856443propranolol hydrochloride 1 MG per ML InjectionSY7da73cee-4e98-462d-e053-2991aa0a8bf48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1338-1516621338011 mL in 1 VIAL (51662-1338-1) 1 ml2018-12-220000-00-00NoNoCurrent
51662-1338-2516621338021 in 1 POUCHHistorical
51662-1338-35166213380310 POUCH in 1 CASE (51662-1338-3) / 1 VIAL in 1 POUCH (51662-1338-2) / 1 mL in 1 VIAL10 pouch2022-10-010000-00-00NoNoCurrent