Propranolol Hydrochloride

Product NDC
70518-3053
Requested package NDC
70518-3053-0
11-digit product format
705183053
Labeler code
70518
Product ID
70518-3053_be250bd4-b607-7550-e053-2a95a90a67ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA070322
Marketing category
ANDA
Marketing start
2021-03-22
Marketing end
0000-00-00
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-305370518-3053-0DDiscontinued by firm2026-08-03

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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

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
A070322-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04
A070322-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22
A070322-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22
A070322-004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22
A070322-005PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070322-001AB
A070322-002AB
A070322-003AB
A070322-004AB
A070322-005AB

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-245bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 195 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070322-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070322-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070322-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070322-005AB15bbf6a4d5a75…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3053-02023-03-15C16284748780-1f386c649-fbd1-0266-e053-dadaa90a7c1aPROPRANOLOL HYDROCHLORIDE TABLETS, USPRx
70518-3053-02023-01-30C16284748780-1f386c649-fbd1-0266-e053-dadaa90a7c1aPROPRANOLOL HYDROCHLORIDE TABLETS, USPRx

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmerican Health Packagingd027f39e-7648-44c8-a8dc-b26b4cdd81be2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDESt. Mary's Medical Park Pharmacyc01fc93e-cff2-50d5-e053-2a95a90a18972026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.07c3fcab-33fe-4a6a-ba67-2d042190c1462026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4a2b8d97-b89b-6b68-e063-6394a90ab3322026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENorthwind Health Company, LLCc29d733a-4fcb-6564-e053-2995a90ae5412026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENorthwind Health Company, LLCda804f70-9558-6e85-e053-2a95a90a90792026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.f7ae2dac-6048-41ea-95d3-cad06cc2baf32025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackcd5cf31d-dade-425f-a32c-2e681a0087872025-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.52da1afc-7f1c-4893-ab84-8479dd9399512025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.582fe781-0759-4622-8fa6-b7d90e94e6962025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.86c48c5a-0a59-43a7-b3b5-41ab5da72ce12025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAsclemed USA, Inc.d08dbabc-8ca4-426e-a9fd-e7914a27883c2025-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.85973689-bb21-483f-becb-c5c8bfb056582025-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackfc1a2e79-3c3b-4e5a-8e75-0fd7abbac5a02025-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECardinal Health 107, LLC1df7f35e-b1d8-4aca-875e-d197cb61239e2025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEDirect Rxd7c0cc12-6d2d-7146-e053-2995a90a85a42025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC29ace768-8fef-482b-e063-6394a90aa2ac2024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.df61a348-0fe9-71c0-e053-2a95a90a9a4c2024-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackcf393c74-381f-4b60-8479-b0763bc71e8e2023-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LP91055555-6967-4b6a-b5c8-5211ec18d2c82023-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3053-07051830530030 TABLET in 1 BLISTER PACK (70518-3053-0) 30 tablet2021-03-220000-00-00NoNoCurrent