Home NDC 0054-3730 Propranolol Hydrochloride
Product NDC 0054-3730
11-digit product format 000543730
Labeler code 0054
Product ID 0054-3730_245a43cc-cbf8-486d-ad3c-724aca63fd72
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propranolol Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA070690
Marketing category ANDA
Marketing start 1987-05-15
Substance PROPRANOLOL HYDROCHLORIDE
Active strength 40 mg/5mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070690-001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 A070690-002 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL AA RS 1987-05-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070690-002 AA
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 · 44 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 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070690-002 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL AA RS 1987-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070690-001 PROPRANOLOL HYDROCHLORIDE 40MG/5ML SOLUTION / ORAL RS 1987-05-15 f41ea6bd6efb…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A070690-002 AA 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A070690-002 AA 1 a50c72e98297…
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/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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856724 Internal RxNorm lookup 856733 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 0054-3730-63 Propranolol Hydrochloride 500 mL in 1 BOTTLE, PLASTIC SOLUTION 500 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROPRANOLOL HYDROCHLORIDE ACTIVE INGREDIENT F8A3652H1V PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 6 PROPRANOLOL ACTIVE MOIETY 9Y8NXQ24VQ PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 6 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 6 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 6 EDETATE CALCIUM DISODIUM INACTIVE INGREDIENT 25IH6R4SGF PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 6 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 6 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 6 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 6 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 6 SORBITOL INACTIVE INGREDIENT 506T60A25R PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 6 WATER INACTIVE INGREDIENT 059QF0KO0R PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-3730 PROPRANOLOL HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 11 Current NDC, Legacy NDC, 1 package rows 20241206_8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e.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 · 1 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 0054-3730-63 00054373063 500 mL in 1 BOTTLE, PLASTIC (0054-3730-63) 500 ml 1987-05-15 0000-00-00 No No Current