FDA.reportPublic FDA data

Propranolol hydrochloride

Product NDC
70756-095
11-digit product format
707560095
Labeler code
70756
Product ID
70756-095_f1ed91cc-9651-41e9-bc21-855bdf78e5fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA216663
Marketing category
ANDA
Marketing start
2026-01-27
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216663-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2026-01-27
A216663-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2026-01-27
A216663-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2026-01-27
A216663-004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2026-01-27
A216663-005PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2026-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A216663-001AB
A216663-002AB
A216663-003AB
A216663-004AB
A216663-005AB

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
2026-09-14 22:38:342026-08A216663-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2026-01-2784e616aacf4f…
2026-09-14 22:38:342026-08A216663-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2026-01-2784e616aacf4f…
2026-09-14 22:38:342026-08A216663-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2026-01-2784e616aacf4f…
2026-09-14 22:38:342026-08A216663-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2026-01-2784e616aacf4f…
2026-09-14 22:38:342026-08A216663-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2026-01-2784e616aacf4f…
2026-08-18 06:07:402026-07A216663-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2026-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07A216663-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2026-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07A216663-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2026-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07A216663-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2026-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07A216663-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2026-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216663-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2026-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216663-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2026-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216663-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2026-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216663-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2026-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216663-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2026-01-27011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216663-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB2026-01-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216663-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB2026-01-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216663-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB2026-01-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216663-004PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2026-01-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216663-005PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB2026-01-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216663-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A216663-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A216663-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A216663-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A216663-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A216663-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216663-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216663-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216663-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216663-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216663-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216663-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216663-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216663-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216663-005AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216663-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216663-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216663-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216663-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216663-005AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856448Internal RxNorm lookup
856457Internal RxNorm lookup
856519Internal RxNorm lookup
856556Internal RxNorm lookup
856578Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
25f9b9a3-7b0b-48d2-a458-c613bedc7cabAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cfProduct name220200609
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
70756-095-11Propranolol hydrochloride100 in 1 BOTTLETABLET1007
70756-095-12Propranolol hydrochloride1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-095-11EA - Each70756-095f798109c-2ea2-412b-8ce7-4a61422c65dd12026-03-17
70756-095-12EA - Each70756-095c8e3095a-9ac8-426d-8f84-07c3942ad55112026-03-17

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol hydrochloridePROPRANOLOL HYDROCHLORIDELifestar Pharma LLC25f9b9a3-7b0b-48d2-a458-c613bedc7cab2026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216663
application number: ANDA216663
ndc (product): 70756-095

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSN25f9b9a3-7b0b-48d2-a458-c613bedc7cab7
856457propranolol HCl 20 MG Oral TabletPSN25f9b9a3-7b0b-48d2-a458-c613bedc7cab7
856519propranolol HCl 40 MG Oral TabletPSN25f9b9a3-7b0b-48d2-a458-c613bedc7cab7
856556propranolol HCl 60 MG Oral TabletPSN25f9b9a3-7b0b-48d2-a458-c613bedc7cab7
856578propranolol HCl 80 MG Oral TabletPSN25f9b9a3-7b0b-48d2-a458-c613bedc7cab7
856448propranolol hydrochloride 10 MG Oral TabletSCD25f9b9a3-7b0b-48d2-a458-c613bedc7cab7
856457propranolol hydrochloride 20 MG Oral TabletSCD25f9b9a3-7b0b-48d2-a458-c613bedc7cab7
856519propranolol hydrochloride 40 MG Oral TabletSCD25f9b9a3-7b0b-48d2-a458-c613bedc7cab7
856556propranolol hydrochloride 60 MG Oral TabletSCD25f9b9a3-7b0b-48d2-a458-c613bedc7cab7
856578propranolol hydrochloride 80 MG Oral TabletSCD25f9b9a3-7b0b-48d2-a458-c613bedc7cab7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-095-1170756009511100 TABLET in 1 BOTTLE (70756-095-11) 100 tablet2026-01-27NoNoCurrent
70756-095-12707560095121000 TABLET in 1 BOTTLE (70756-095-12) 1000 tablet2026-01-27NoNoCurrent