Home NDC 68788-8620 Propranolol Hydrochloride
Product NDC 68788-8620
11-digit product format 687888620
Labeler code 68788
Product ID 68788-8620_15335091-96cd-46c0-acfa-c1af3e9ec47d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propranolol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA070322
Marketing category ANDA
Marketing start 2024-04-02
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070322-001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1986-08-04 A070322-002 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-10-22 A070322-003 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-10-22 A070322-004 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-10-22 A070322-005 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 220 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 2026-10-15 13:18:30 2026-09 A070322-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1986-08-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A070322-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-10-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A070322-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-10-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A070322-004 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-10-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A070322-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-09-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 A070322-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1986-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A070322-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A070322-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A070322-004 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A070322-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A070322-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1986-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070322-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070322-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070322-004 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070322-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070322-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1986-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070322-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070322-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070322-004 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070322-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070322-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1986-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070322-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070322-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070322-004 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070322-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070322-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1986-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070322-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070322-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070322-004 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070322-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070322-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1986-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070322-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070322-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070322-004 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070322-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070322-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1986-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070322-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070322-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070322-004 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070322-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-09-24 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 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 68788-8620-1 Propranolol Hydrochloride 100 in 1 BOTTLE TABLET 100 2 68788-8620-3 Propranolol Hydrochloride 30 in 1 BOTTLE TABLET 30 2 68788-8620-6 Propranolol Hydrochloride 60 in 1 BOTTLE TABLET 60 2 68788-8620-9 Propranolol Hydrochloride 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8620 PROPRANOLOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] 1 Current NDC, 4 package rows 20240413_52da1afc-7f1c-4893-ab84-8479dd939951.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 · 21 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 68788-8620-1 68788862001 100 TABLET in 1 BOTTLE (68788-8620-1) 100 tablet 2024-04-02 No No Current 68788-8620-3 68788862003 30 TABLET in 1 BOTTLE (68788-8620-3) 30 tablet 2024-04-02 No No Current 68788-8620-6 68788862006 60 TABLET in 1 BOTTLE (68788-8620-6) 60 tablet 2024-04-02 No No Current 68788-8620-9 68788862009 90 TABLET in 1 BOTTLE (68788-8620-9) 90 tablet 2024-04-02 No No Current