Home NDC 82619-133-02 Propranolol Hydrochloride
Product NDC 82619-133
Requested package NDC 82619-133-02
11-digit product format 826190133
Labeler code 82619
Product ID 82619-133_598d91b8-2d91-47e7-e063-6294a90a248a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propranolol Hydrochloride
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Creekwood Pharmaceuticals LLC
Application ANDA219460
Marketing category ANDA
Marketing start 2026-08-29
Substance PROPRANOLOL HYDROCHLORIDE
Active strength 80 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219460-001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-08-14 A219460-002 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-08-14 A219460-003 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-08-14 A219460-004 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-08-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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.
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 A219460-001 PROPRANOLOL HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219460-002 PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219460-003 PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219460-004 PROPRANOLOL HYDROCHLORIDE 160MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-08-14 84e616aacf4f…
Observed Orange Book normalized TE history# 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 80 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856460 Internal RxNorm lookup 856481 Internal RxNorm lookup 856535 Internal RxNorm lookup 856569 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82619-133-02 82619013302 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82619-133-02) 2026-08-29 No No Current