FDA.reportPublic FDA data

propranolol hydrochloride

Product NDC
51991-820
11-digit product format
519910820
Labeler code
51991
Product ID
51991-820_f7b4203a-c93c-47a2-9ad0-41df7d7a2c26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA078703
Marketing category
ANDA
Marketing start
2013-03-11
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
160 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
propranolol hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856460, 856481, 856535, 856569

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
51991-820-01propranolol hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10011
51991-820-05propranolol hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-820-01EA - Each51991-820f6bb0343-7a97-4573-b346-96af62a7b15312013-04-01
51991-820-05EA - Each51991-820273a84a0-d313-4f9d-8ff8-b65c755ad3fd12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
propranolol hydrochlorideACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
propranololACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
ammoniaINACTIVE INGREDIENT5138Q19F1XPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
diethyl phthalateINACTIVE INGREDIENTUF064M00AFPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
ethylcellulose (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
ferric oxide redINACTIVE INGREDIENT1K09F3G675PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
gelatinINACTIVE INGREDIENT2G86QN327LPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
hypromellose phthalate (24% phthalate, 55 CST)INACTIVE INGREDIENT87Y6436BKRPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
povidone K29/32INACTIVE INGREDIENT390RMW2PEQPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
starch, cornINACTIVE INGREDIENTO8232NY3SJPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
sucroseINACTIVE INGREDIENTC151H8M554PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-820PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]10Current NDC, Legacy NDC, 2 package rows20240327_179e31a7-9956-4fba-9e9a-2ca28d37d42b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856481propranolol HCl 160 MG 24HR Extended Release Oral CapsulePSN44a7900c-b240-4e04-954e-2671d4d51ae7103
85648124 HR propranolol hydrochloride 160 MG Extended Release Oral CapsuleSCD44a7900c-b240-4e04-954e-2671d4d51ae7103
856481propranolol hydrochloride 160 MG 24 HR Extended Release Oral CapsuleSY44a7900c-b240-4e04-954e-2671d4d51ae7103
856481propranolol HCl 160 MG 24HR Extended Release Oral CapsulePSN5cf8d0a4-4e02-48f0-8d1f-564357b250c5102
85648124 HR propranolol hydrochloride 160 MG Extended Release Oral CapsuleSCD5cf8d0a4-4e02-48f0-8d1f-564357b250c5102
856481propranolol hydrochloride 160 MG 24 HR Extended Release Oral CapsuleSY5cf8d0a4-4e02-48f0-8d1f-564357b250c5102
856460propranolol HCl 120 MG 24HR Extended Release Oral CapsulePSN179e31a7-9956-4fba-9e9a-2ca28d37d42b11
856481propranolol HCl 160 MG 24HR Extended Release Oral CapsulePSN179e31a7-9956-4fba-9e9a-2ca28d37d42b11
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN179e31a7-9956-4fba-9e9a-2ca28d37d42b11
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN179e31a7-9956-4fba-9e9a-2ca28d37d42b11
85646024 HR propranolol hydrochloride 120 MG Extended Release Oral CapsuleSCD179e31a7-9956-4fba-9e9a-2ca28d37d42b11
85648124 HR propranolol hydrochloride 160 MG Extended Release Oral CapsuleSCD179e31a7-9956-4fba-9e9a-2ca28d37d42b11
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD179e31a7-9956-4fba-9e9a-2ca28d37d42b11
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD179e31a7-9956-4fba-9e9a-2ca28d37d42b11
856460propranolol hydrochloride 120 MG 24 HR Extended Release Oral CapsuleSY179e31a7-9956-4fba-9e9a-2ca28d37d42b11
856481propranolol hydrochloride 160 MG 24 HR Extended Release Oral CapsuleSY179e31a7-9956-4fba-9e9a-2ca28d37d42b11
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY179e31a7-9956-4fba-9e9a-2ca28d37d42b11
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY179e31a7-9956-4fba-9e9a-2ca28d37d42b11
856460propranolol HCl 120 MG 24HR Extended Release Oral CapsulePSN753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856481propranolol HCl 160 MG 24HR Extended Release Oral CapsulePSN753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN753ab3cb-e7ee-424b-aa7d-195b5871a40e9
85646024 HR propranolol hydrochloride 120 MG Extended Release Oral CapsuleSCD753ab3cb-e7ee-424b-aa7d-195b5871a40e9
85648124 HR propranolol hydrochloride 160 MG Extended Release Oral CapsuleSCD753ab3cb-e7ee-424b-aa7d-195b5871a40e9
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD753ab3cb-e7ee-424b-aa7d-195b5871a40e9
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856460propranolol hydrochloride 120 MG 24 HR Extended Release Oral CapsuleSY753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856481propranolol hydrochloride 160 MG 24 HR Extended Release Oral CapsuleSY753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY753ab3cb-e7ee-424b-aa7d-195b5871a40e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51991-820-0151991082001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51991-820-01) 2013-03-110000-00-00NoNoCurrent
51991-820-0551991082005500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51991-820-05) 2013-03-110000-00-00NoNoCurrent