FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
42689-014
Requested package NDC
42689-014-10
11-digit product format
426890014
Labeler code
42689
Product ID
42689-014_81548a65-4cc7-4e02-9846-590737a74469
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Nortec Development Associates, Inc
Application
ANDA078065
Marketing category
ANDA
Marketing start
2015-05-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42689-01442689-014-10IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078065-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-01-26
A078065-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-01-26
A078065-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-01-26
A078065-004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-01-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A078065-001AB
A078065-002AB
A078065-003AB
A078065-004AB

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
2026-08-01 22:54:322026-06A078065-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-01-26a50c72e98297…
2026-08-01 22:54:322026-06A078065-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-01-26a50c72e98297…
2026-08-01 22:54:322026-06A078065-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-01-26a50c72e98297…
2026-08-01 22:54:322026-06A078065-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-01-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078065-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078065-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078065-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A078065-004AB1a50c72e98297…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42689-014-012026-01-29C16284748780-1ba0f9c33-4695-a910-e053-dadaa90a0b85Rx Only
42689-014-102026-01-29C16284748780-1ba0f9c33-4695-a910-e053-dadaa90a0b85Rx Only
42689-014-012022-12-21C16284748780-1ba0f9c33-4695-a910-e053-dadaa90a0b85Rx Only
42689-014-102022-12-21C16284748780-1ba0f9c33-4695-a910-e053-dadaa90a0b85Rx Only
42689-014-012021-01-29C16284748780-1ba0f9c33-4695-a910-e053-dadaa90a0b85Rx Only
42689-014-102021-01-29C16284748780-1ba0f9c33-4695-a910-e053-dadaa90a0b85Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42689-014-01Propranolol Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1005
42689-014-10Propranolol Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Propranolol HydrochlorideACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]1
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]1
ETHYLCELLULOSE (45 MPA.S)INACTIVE INGREDIENTV7AD894FAZPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]1
GELATININACTIVE INGREDIENT2G86QN327LPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42689-014PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]5Legacy NDC, 2 package rows20241204_b756f602-62c9-41ef-a934-834ac81b46ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856460propranolol HCl 120 MG 24HR Extended Release Oral CapsulePSNb756f602-62c9-41ef-a934-834ac81b46ae5
856481propranolol HCl 160 MG 24HR Extended Release Oral CapsulePSNb756f602-62c9-41ef-a934-834ac81b46ae5
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSNb756f602-62c9-41ef-a934-834ac81b46ae5
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSNb756f602-62c9-41ef-a934-834ac81b46ae5
85646024 HR propranolol hydrochloride 120 MG Extended Release Oral CapsuleSCDb756f602-62c9-41ef-a934-834ac81b46ae5
85648124 HR propranolol hydrochloride 160 MG Extended Release Oral CapsuleSCDb756f602-62c9-41ef-a934-834ac81b46ae5
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCDb756f602-62c9-41ef-a934-834ac81b46ae5
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCDb756f602-62c9-41ef-a934-834ac81b46ae5
856460propranolol hydrochloride 120 MG 24 HR Extended Release Oral CapsuleSYb756f602-62c9-41ef-a934-834ac81b46ae5
856481propranolol hydrochloride 160 MG 24 HR Extended Release Oral CapsuleSYb756f602-62c9-41ef-a934-834ac81b46ae5
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSYb756f602-62c9-41ef-a934-834ac81b46ae5
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSYb756f602-62c9-41ef-a934-834ac81b46ae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42689-014-10426890014101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-014-10) 2015-05-010000-00-00NoNoCurrent