Home NDC 71863-132 HEMANGEOL
Product NDC 71863-132
11-digit product format 718630132
Labeler code 71863
Product ID 71863-132_5a6dc9b7-4cbd-13a7-e063-6394a90a4af4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propranolol Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Eton Pharmaceuticals, Inc.
Application NDA205410
Marketing category NDA
Marketing start 2026-04-16
Substance PROPRANOLOL HYDROCHLORIDE
Active strength 4.28 mg/mL
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 N205410-001 HEMANGEOL PROPRANOLOL HYDROCHLORIDE 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205410-001 8338489 2028-10-16 U-1496 2014-03-28 N205410-001 8987262 2028-10-16 U-1988 2017-04-14
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 · 43 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 2026-09-14 22:38:34 2026-08 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205410-001 HEMANGEOL 4.28MG/ML SOLUTION / ORAL RLD, RS 2014-03-14 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205410-001 8338489 2028-10-16 U-1496 2014-03-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205410-001 8987262 2028-10-16 U-1988 2017-04-14 74a2ff9319b5…
Observed Orange Book exclusivity 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 HEMANGEOL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPRANOLOL HYDROCHLORIDE 4.28 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71863-132-12 HEMANGEOL 120 mL in 1 CONTAINER SOLUTION 120 4 71863-132-50 HEMANGEOL 50 mL in 1 CONTAINER SOLUTION 50 4 71863-132-51 HEMANGEOL 50 mL in 1 CONTAINER SOLUTION 50 4
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HEMANGEOL PROPRANOLOL HYDROCHLORIDE Pierre Fabre Pharmaceuticals, Inc. b6f9dd2a-632b-87eb-70f0-b2064d7ed48a 2026-06-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 205410 application number: NDA205410
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71863-132-12 71863013212 120 mL in 1 CONTAINER (71863-132-12) 120 ml 2026-04-16 No No Current 71863-132-50 71863013250 50 mL in 1 CONTAINER (71863-132-50) 50 ml 2026-04-16 No No Current 71863-132-51 71863013251 50 mL in 1 CONTAINER (71863-132-51) 50 ml 2026-05-27 Yes No Current