Home NDC 71610-339 Propranolol Hydrochloride
Product NDC 71610-339
11-digit product format 716100339
Labeler code 71610
Product ID 71610-339_c8c0bd51-a7c2-4d89-bee2-063cd4da43f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name propranolol hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA070213
Marketing category ANDA
Marketing start 1985-11-19
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 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070213-001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 A070213-002 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 A070213-003 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 A070213-004 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 A070213-005 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08
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 · 210 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 2026-08-18 06:07:40 2026-07 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Propranolol Hydrochloride
Listing expiration 2026-12-31 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 71610-339-45 Propranolol Hydrochloride 45 in 1 BOTTLE, PLASTIC TABLET 45 2 71610-339-60 Propranolol Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-339 PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20210703_3c05ab1f-05b0-494a-b640-667e7cf517a1.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 1 of 1 · 4 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 71610-339-45 71610033945 45 TABLET in 1 BOTTLE, PLASTIC (71610-339-45) 45 tablet 2021-05-07 0000-00-00 No No Current 71610-339-60 71610033960 90 TABLET in 1 BOTTLE, PLASTIC (71610-339-60) 90 tablet 2019-08-20 0000-00-00 No No Current