Home NDC 72789-423 Propranolol Hydrochloride
Product NDC 72789-423
11-digit product format 727890423
Labeler code 72789
Product ID 72789-423_57c4701b-9a1f-226e-e063-6394a90ac79c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propranolol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA071972
Marketing category ANDA
Marketing start 2021-06-03
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 · 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 20 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 856457 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 72789-423-30 Propranolol Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET 30 7 72789-423-60 Propranolol Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET 60 7 72789-423-90 Propranolol Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-423 PROPRANOLOL HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 5 Current NDC, 3 package rows 20241225_49d09308-74b0-4f9a-9c03-37234b5ee3a3.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 Sample Exclude flag Status 72789-423-30 72789042330 30 TABLET in 1 BOTTLE, PLASTIC (72789-423-30) 30 tablet 2024-07-12 No No Current 72789-423-60 72789042360 60 TABLET in 1 BOTTLE, PLASTIC (72789-423-60) 60 tablet 2024-12-23 No No Current 72789-423-90 72789042390 90 TABLET in 1 BOTTLE, PLASTIC (72789-423-90) 90 tablet 2025-06-03 No No Current