Propranolol Hydrochloride

Product NDC
0615-2561
11-digit product format
006152561
Labeler code
0615
Product ID
0615-2561_631fbd02-ac53-4b98-bda2-827ee4438c0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA070213
Marketing category
ANDA
Marketing start
1985-11-19
Marketing end
0000-00-00
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-2561DDiscontinued by firm2026-08-17
excluded packagepackage0615-25610615-2561-31DDiscontinued by firm2026-08-17
excluded packagepackage0615-25610615-2561-39DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-2561-39DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-2561-31DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-2561-39DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-2561-31DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-2561-39DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-2561-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-2561-39DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-2561-31DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-2561-39DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-2561-31DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-2561-39DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-2561-31DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-2561-39DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-2561-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-2561-39DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-2561-31DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-2561-39DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-2561-31DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-2561-39DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-2561-31DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-2561-39DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-2561-31DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-2561-39DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-2561-31DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0615-2561-31IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0615-2561-39IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0615-2561-31IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0615-2561-39IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0615-2561-39EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0615-2561-31EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0615-2561-312021-08-12Propranolol Hydrochloride
0615-2561-392021-08-12Propranolol Hydrochloride
0615-2561-312020-01-31Propranolol Hydrochloride
0615-2561-392020-01-31Propranolol Hydrochloride

DailyMed Socrata Ingredients#

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
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3c05ab1f-05b0-494a-b640-667e7cf517a12021-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070213
application number: ANDA070213