Home NDC 70518-3377 Propranolol Hydrochloride
Product NDC 70518-3377
11-digit product format 705183377
Labeler code 70518
Product ID 70518-3377_5874caea-a851-51a1-e063-6394a90ada36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propranolol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA071972
Marketing category ANDA
Marketing start 2022-03-06
Substance PROPRANOLOL HYDROCHLORIDE
Active strength 40 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
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071972-001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 A071972-002 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 A071972-003 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071972-002 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1988-04-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071972-003 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1988-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071972-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1988-04-06 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 observed states.
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 Ingredient Strength PROPRANOLOL HYDROCHLORIDE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F8A3652H1V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856519 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-3377-0 Propranolol Hydrochloride 30 in 1 BLISTER PACK TABLET 30 8 70518-3377-1 Propranolol Hydrochloride 100 in 1 BOX TABLET 100 8 70518-3377-2 Propranolol Hydrochloride 1 in 1 POUCH TABLET 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3377 PROPRANOLOL HYDROCHLORIDE TABLET [REMEDYREPACK INC.] 5 Current NDC, Legacy NDC, 3 package rows 20241004_e3f615e0-07da-491c-9620-7083f4f4318a.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 2 of 2 · 25 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-3377-0 70518337700 30 TABLET in 1 BLISTER PACK (70518-3377-0) 30 tablet 2022-03-06 0000-00-00 No No Current 70518-3377-1 70518337701 100 POUCH in 1 BOX (70518-3377-1) > 1 TABLET in 1 POUCH (70518-3377-2) 100 pouch 2022-04-06 0000-00-00 No No Current 70518-3377-2 70518337702 1 in 1 POUCH Historical