HEMANGEOL

Product NDC
71863-132
11-digit product format
718630132
Labeler code
71863
Product ID
71863-132_50b2c56d-215c-a2cb-e063-6394a90a0a28
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205410-001HEMANGEOLPROPRANOLOL HYDROCHLORIDE4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205410-00183384892028-10-16U-14962014-03-28
N205410-00189872622028-10-16U-19882017-04-14

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-143f01610625f2…
2019-09-15 20:21 UTC2019-09N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N205410-001HEMANGEOL4.28MG/MLSOLUTION / ORALRLD, RS2014-03-14e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N205410-00183384892028-10-16U-14962014-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N205410-00189872622028-10-16U-19882017-04-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205410-00183384892028-10-16U-14962014-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205410-00189872622028-10-16U-19882017-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205410-00183384892028-10-16U-14962014-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205410-00189872622028-10-16U-19882017-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N205410-00183384892028-10-16U-14962014-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205410-00189872622028-10-16U-19882017-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205410-00183384892028-10-16U-14962014-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205410-00189872622028-10-16U-19882017-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205410-00183384892028-10-16U-14962014-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205410-00189872622028-10-16U-19882017-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205410-00183384892028-10-16U-14962014-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205410-00189872622028-10-16U-19882017-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205410-00183384892028-10-16U-14962014-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205410-00189872622028-10-16U-19882017-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205410-00183384892028-10-16U-14962014-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205410-00189872622028-10-16U-19882017-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205410-00183384892028-10-16U-14962014-03-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205410-00189872622028-10-16U-19882017-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205410-00183384892028-10-16U-14962014-03-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N205410-00189872622028-10-16U-19882017-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205410-00183384892028-10-16U-14962014-03-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205410-00189872622028-10-16U-19882017-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205410-00183384892028-10-16U-14962014-03-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205410-00189872622028-10-16U-19882017-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205410-00183384892028-10-16U-14962014-03-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205410-00189872622028-10-16U-19882017-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205410-00183384892028-10-16U-14962014-03-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N205410-00189872622028-10-16U-19882017-04-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205410-00183384892028-10-16U-14962014-03-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205410-00189872622028-10-16U-19882017-04-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205410-00183384892028-10-16U-14962014-03-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205410-00189872622028-10-16U-19882017-04-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205410-00183384892028-10-16U-14962014-03-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N205410-00189872622028-10-16U-19882017-04-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205410-00183384892028-10-16U-14962014-03-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205410-00189872622028-10-16U-19882017-04-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205410-00183384892028-10-16U-14962014-03-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N205410-00189872622028-10-16U-19882017-04-14bb7c543d1eb4…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N205410-001ODE-622021-03-1474a2ff9319b5…
2021-12-28 21:50 UTC2021-12N205410-001ODE-622021-03-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205410-001ODE-622021-03-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N205410-001ODE-622021-03-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205410-001ODE-622021-03-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205410-001ODE-622021-03-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205410-001ODE-622021-03-143f01610625f2…
2019-09-15 20:21 UTC2019-09N205410-001ODE-622021-03-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N205410-001ODE-622021-03-14ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
HEMANGEOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE4.28 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F8A3652H1VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1495058Internal RxNorm lookup
1495064Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f8341ee-dac6-1ca9-e063-6394a90ac960Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cfProduct name220200609
a5696e6c-a559-4d6b-bb53-f324106f317cProduct name120140718
0f446d3d-c9e6-1844-b8e8-a836dc35e0deProduct name120140508
33a4b7b4-a3c1-3f95-a202-01166dd77c44Product name120140508
60519d27-227d-404a-38bc-37524c8b386bProduct name120140508
d5f30598-8f94-b083-f161-65d67f2ae12aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71863-132-12HEMANGEOL120 mL in 1 CONTAINERSOLUTION1204
71863-132-50HEMANGEOL50 mL in 1 CONTAINERSOLUTION504
71863-132-51HEMANGEOL50 mL in 1 CONTAINERSOLUTION504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71863-132-12ML - Milliliter71863-13287005e87-aaea-47c4-bad0-1dda934535a512026-05-22
71863-132-50ML - Milliliter71863-132bce9a6b3-9b93-403f-a5bc-db1edb0341d912026-05-22

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEMANGEOLPROPRANOLOL HYDROCHLORIDEPierre Fabre Pharmaceuticals, Inc.b6f9dd2a-632b-87eb-70f0-b2064d7ed48a2026-06-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 205410
application number: NDA205410
HEMANGEOLPROPRANOLOL HYDROCHLORIDEEton Pharmaceuticals, Inc.4f8341ee-dac6-1ca9-e063-6394a90ac9602026-05-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 205410
application number: NDA205410
ndc (product): 71863-132

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1495064Hemangeol 4.28 MG in 1 mL Oral SolutionPSN4f8341ee-dac6-1ca9-e063-6394a90ac9604
1495058propranolol HCl 4.28 MG in 1 mL Oral SolutionPSN4f8341ee-dac6-1ca9-e063-6394a90ac9604
1495064propranolol hydrochloride 4.28 MG/ML Oral Solution [Hemangeol]SBD4f8341ee-dac6-1ca9-e063-6394a90ac9604
1495058propranolol hydrochloride 4.28 MG/ML Oral SolutionSCD4f8341ee-dac6-1ca9-e063-6394a90ac9604
1495064Hemangeol 4.28 MG per 1 ML Oral SolutionSY4f8341ee-dac6-1ca9-e063-6394a90ac9604
1495064Hemangeol 4.28 MG/ML (as propranolol 3.75 MG/ML) Oral SolutionSY4f8341ee-dac6-1ca9-e063-6394a90ac9604
1495058propranolol HCl 4.28 MG/ML (as propranolol 3.75 MG/ML) Oral SolutionSY4f8341ee-dac6-1ca9-e063-6394a90ac9604
1495058propranolol hydrochloride 4.28 MG per 1 ML Oral SolutionSY4f8341ee-dac6-1ca9-e063-6394a90ac9604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71863-132-1271863013212120 mL in 1 CONTAINER (71863-132-12) 120 ml2026-04-16NoNoCurrent
71863-132-507186301325050 mL in 1 CONTAINER (71863-132-50) 50 ml2026-04-16NoNoCurrent
71863-132-517186301325150 mL in 1 CONTAINER (71863-132-51)50 ml2026-05-271Current