Propranolol Hydrochloride

Product NDC
0378-0185
11-digit product format
003780185
Labeler code
0378
Product ID
0378-0185_4b043e3b-c0dc-4e37-a2fb-86c51a99c054
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA070213
Marketing category
ANDA
Marketing start
1985-11-19
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
80 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 42.

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
A070213-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-19
A070213-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-19
A070213-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-19
A070213-004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-19
A070213-005PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070213-001AB
A070213-002AB
A070213-003AB
A070213-004AB
A070213-005AB

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.

Product history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-082680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A070213-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070213-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070213-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-005AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE80 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
b94dcec7-7633-4a33-9cea-48161adeaf93Available on FDA.report

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
0378-0185-01Propranolol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10013
0378-0185-05Propranolol Hydrochloride500 in 1 BOTTLE, PLASTICTABLET50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0185-01EA - Each0378-0185029da63a-48c5-48df-b17a-0758fb33345912012-07-24
0378-0185-05EA - Each0378-0185dd226a1f-3f22-4b21-a066-fb5728587c2512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0185PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20240420_b94dcec7-7633-4a33-9cea-48161adeaf93.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEGolden State Medical Supply, Inc.8cbac6dc-ef1d-6662-e053-2995a90af13f2026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070213
application number: ANDA070213
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC7da9bb37-cc22-4eff-8de0-429f64cb599e2026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070213
application number: ANDA070213
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEMylan Pharmaceuticals Inc.b94dcec7-7633-4a33-9cea-48161adeaf932026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070213
application number: ANDA070213
ndc (product): 0378-0185
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3c05ab1f-05b0-494a-b640-667e7cf517a12021-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070213
application number: ANDA070213

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSNb94dcec7-7633-4a33-9cea-48161adeaf9313
856457propranolol HCl 20 MG Oral TabletPSNb94dcec7-7633-4a33-9cea-48161adeaf9313
856519propranolol HCl 40 MG Oral TabletPSNb94dcec7-7633-4a33-9cea-48161adeaf9313
856556propranolol HCl 60 MG Oral TabletPSNb94dcec7-7633-4a33-9cea-48161adeaf9313
856578propranolol HCl 80 MG Oral TabletPSNb94dcec7-7633-4a33-9cea-48161adeaf9313
856448propranolol hydrochloride 10 MG Oral TabletSCDb94dcec7-7633-4a33-9cea-48161adeaf9313
856457propranolol hydrochloride 20 MG Oral TabletSCDb94dcec7-7633-4a33-9cea-48161adeaf9313
856519propranolol hydrochloride 40 MG Oral TabletSCDb94dcec7-7633-4a33-9cea-48161adeaf9313
856556propranolol hydrochloride 60 MG Oral TabletSCDb94dcec7-7633-4a33-9cea-48161adeaf9313
856578propranolol hydrochloride 80 MG Oral TabletSCDb94dcec7-7633-4a33-9cea-48161adeaf9313
856448propranolol HCl 10 MG Oral TabletPSN8cbac6dc-ef1d-6662-e053-2995a90af13f7
856457propranolol HCl 20 MG Oral TabletPSN8cbac6dc-ef1d-6662-e053-2995a90af13f7
856519propranolol HCl 40 MG Oral TabletPSN8cbac6dc-ef1d-6662-e053-2995a90af13f7
856556propranolol HCl 60 MG Oral TabletPSN8cbac6dc-ef1d-6662-e053-2995a90af13f7
856578propranolol HCl 80 MG Oral TabletPSN8cbac6dc-ef1d-6662-e053-2995a90af13f7
856448propranolol hydrochloride 10 MG Oral TabletSCD8cbac6dc-ef1d-6662-e053-2995a90af13f7
856457propranolol hydrochloride 20 MG Oral TabletSCD8cbac6dc-ef1d-6662-e053-2995a90af13f7
856519propranolol hydrochloride 40 MG Oral TabletSCD8cbac6dc-ef1d-6662-e053-2995a90af13f7
856556propranolol hydrochloride 60 MG Oral TabletSCD8cbac6dc-ef1d-6662-e053-2995a90af13f7
856578propranolol hydrochloride 80 MG Oral TabletSCD8cbac6dc-ef1d-6662-e053-2995a90af13f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0185-0100378018501100 TABLET in 1 BOTTLE, PLASTIC (0378-0185-01) 100 tablet1985-11-190000-00-00NoNoCurrent
0378-0185-0500378018505500 TABLET in 1 BOTTLE, PLASTIC (0378-0185-05) 500 tablet1985-11-190000-00-00NoNoCurrent