Home NDC 0121-4958 Propranolol Hydrochloride
Product NDC 0121-4958
11-digit product format 001214958
Labeler code 0121
Product ID 0121-4958_dc246a80-abe2-4ee7-b3c6-1ef93dad5e1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propranolol Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA219165
Marketing category ANDA
Marketing start 2026-08-19
Substance PROPRANOLOL HYDROCHLORIDE
Active strength 20 mg/5mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219165-001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL AA 2026-06-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219165-001 AA
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A219165-001 CGT 2027-02-15
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 A219165-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL AA 2026-06-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219165-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL AA 2026-06-10 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219165-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL AA 2026-06-10 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A219165-001 AA 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219165-001 AA 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219165-001 AA 1 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 A219165-001 CGT 2027-02-15 84e616aacf4f…
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/5mL
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 856724 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 Units Marketing start Sample Exclude flag Status 0121-4958-40 00121495840 4 TRAY in 1 CASE (0121-4958-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4958-05) 4 tray 2026-08-19 No No Current