Home NDC 63323-604 Propranolol
Product NDC 63323-604
11-digit product format 633230604
Labeler code 63323
Product ID 63323-604_505851c4-b18c-4cd7-805c-4e923cc1fa7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROPRANOLOL HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA075826
Marketing category ANDA
Marketing start 2001-09-07
Substance PROPRANOLOL HYDROCHLORIDE
Active strength 1 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075826-001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075826-001 AP
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 2 · 42 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 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075826-001 PROPRANOLOL HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2001-08-31 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Propranolol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPRANOLOL HYDROCHLORIDE 1 mg/mL
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 856443 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 63323-604-01 Propranolol 10 in 1 TRAY INJECTION, SOLUTION 10 4 63323-604-01 Propranolol 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-604 PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20230119_f14ea537-dd5c-4c78-9037-9a85e9e610ef.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PROPRANOLOL PROPRANOLOL HF Acquisition Co LLC, DBA HealthFirst 54dd0fad-64ee-788f-e063-6394a90ac88e 2026-06-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075826 application number: ANDA075826 Propranolol PROPRANOLOL HYDROCHLORIDE ProPharma Distribution 45b0aaf0-df6c-7db0-e063-6294a90a9135 2025-12-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075826 application number: ANDA075826 PROPRANOLOL PROPRANOLOL HYDROCHLORIDE Henry Schein, Inc. e586996d-9035-4ef4-8c8d-06e70a02577f 2025-11-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075826 application number: ANDA075826 Propranolol PROPRANOLOL HYDROCHLORIDE Medical Purchasing Solutions, LLC 9e50d1ee-b7f3-e549-e053-2995a90a4a86 2023-05-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075826 application number: ANDA075826 Propranolol PROPRANOLOL HYDROCHLORIDE Fresenius Kabi USA, LLC f14ea537-dd5c-4c78-9037-9a85e9e610ef 2023-01-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075826 application number: ANDA075826 ndc (product): 63323-604
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63323-604-01 63323060401 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-604-01) / 1 mL in 1 VIAL, SINGLE-DOSE 2001-09-07 0000-00-00 No No Current