FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
71610-987
11-digit product format
716100987
Labeler code
71610
Product ID
71610-987_4a2b8d97-b89c-6b68-e063-6394a90ab332
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA070322
Marketing category
ANDA
Marketing start
2019-10-31
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Propranolol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856457

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
71610-987-53Propranolol Hydrochloride60 in 1 BOTTLETABLET601
71610-987-60Propranolol Hydrochloride90 in 1 BOTTLETABLET901
71610-987-70Propranolol Hydrochloride120 in 1 BOTTLETABLET1201
71610-987-80Propranolol Hydrochloride180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-987-53EA - Each71610-9876a3e6eaa-ca64-494d-a662-2064b930f77b12026-03-17
71610-987-60EA - Each71610-987319bcdd5-c21b-4874-9103-ed7a41e908b712026-03-17
71610-987-70EA - Each71610-98793169d8b-769f-4dc8-82d0-791110f5cfd812026-03-17
71610-987-80EA - Each71610-9873559a448-18a2-4250-b060-903efc89f84c12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856457propranolol HCl 20 MG Oral TabletPSN4a2b8d97-b89b-6b68-e063-6394a90ab3321
856457propranolol hydrochloride 20 MG Oral TabletSCD4a2b8d97-b89b-6b68-e063-6394a90ab3321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-987-537161009875360 TABLET in 1 BOTTLE (71610-987-53) 60 tablet2026-02-06NoNoHistorical
71610-987-607161009876090 TABLET in 1 BOTTLE (71610-987-60) 90 tablet2026-02-06NoNoHistorical
71610-987-7071610098770120 TABLET in 1 BOTTLE (71610-987-70) 120 tablet2026-02-06NoNoHistorical
71610-987-8071610098780180 TABLET in 1 BOTTLE (71610-987-80) 180 tablet2026-02-06NoNoHistorical