InnoPran XL

Product NDC
62559-591
11-digit product format
625590591
Labeler code
62559
Product ID
62559-591_65c78569-68fb-49ac-aa09-96b1fc5a01d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA021438
Marketing category
NDA
Marketing start
2018-02-22
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
120 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
InnoPran XL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856460, 856471, 856569, 856576

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
62559-591-14InnoPran XL14 in 1 BOTTLECAPSULE, EXTENDED RELEASE147
62559-591-30InnoPran XL30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307
62559-591-77InnoPran XL7 in 1 BOTTLECAPSULE, EXTENDED RELEASE77

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-591-30EA - Each62559-5918a40c30c-e419-4cb5-8988-702dbf30fbd712018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-591INNOPRAN XL (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 3 package rows20240322_cd5601b3-4d87-4c3b-acac-b476e787609d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856471InnoPran XL 120 MG 24HR Extended Release Oral CapsulePSNcd5601b3-4d87-4c3b-acac-b476e787609d7
856576InnoPran XL 80 MG 24HR Extended Release Oral CapsulePSNcd5601b3-4d87-4c3b-acac-b476e787609d7
856460propranolol HCl 120 MG 24HR Extended Release Oral CapsulePSNcd5601b3-4d87-4c3b-acac-b476e787609d7
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSNcd5601b3-4d87-4c3b-acac-b476e787609d7
85647124 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule [InnoPran]SBDcd5601b3-4d87-4c3b-acac-b476e787609d7
85657624 HR propranolol hydrochloride 80 MG Extended Release Oral Capsule [InnoPran]SBDcd5601b3-4d87-4c3b-acac-b476e787609d7
85646024 HR propranolol hydrochloride 120 MG Extended Release Oral CapsuleSCDcd5601b3-4d87-4c3b-acac-b476e787609d7
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCDcd5601b3-4d87-4c3b-acac-b476e787609d7
856471InnoPran XL 120 MG 24 HR Extended Release Oral CapsuleSYcd5601b3-4d87-4c3b-acac-b476e787609d7
856576InnoPran XL 80 MG 24 HR Extended Release Oral CapsuleSYcd5601b3-4d87-4c3b-acac-b476e787609d7
856460propranolol hydrochloride 120 MG 24 HR Extended Release Oral CapsuleSYcd5601b3-4d87-4c3b-acac-b476e787609d7
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSYcd5601b3-4d87-4c3b-acac-b476e787609d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-591-146255905911414 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-591-14) 2021-09-010000-00-00YesNoCurrent
62559-591-306255905913030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-591-30) 2018-02-220000-00-00NoNoCurrent
62559-591-77625590591777 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-591-77) 2018-02-220000-00-00YesNoCurrent