HEMANGEOL

Product NDC: 64370-375
11-digit product format: 643700375
Labeler code: 64370
Product ID: 64370-375_4629077d-5a4b-443a-e063-6294a90a48ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propranolol hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Pierre Fabre Pharmaceuticals, Inc.
Application: NDA205410
Marketing category: NDA
Marketing start: 2014-04-14
Marketing end: 2028-09-30
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205410-001	HEMANGEOL	4.28MG/ML	SOLUTION / ORAL	RLD, RS	2014-03-14	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205410-001	8338489	2028-10-16	U-1496	2014-03-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205410-001	8987262	2028-10-16	U-1988	2017-04-14	`782e0a99824c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205410-001	ODE-62	2021-03-14	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N205410-001	ODE-62	2021-03-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205410-001	ODE-62	2021-03-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205410-001	ODE-62	2021-03-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205410-001	ODE-62	2021-03-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205410-001	ODE-62	2021-03-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205410-001	ODE-62	2021-03-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205410-001	ODE-62	2021-03-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205410-001	ODE-62	2021-03-14	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: HEMANGEOL

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROPRANOLOL HYDROCHLORIDE	4.28 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 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b6f9dd2a-632b-87eb-70f0-b2064d7ed48a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cf	Product name	2	20200609
a5696e6c-a559-4d6b-bb53-f324106f317c	Product name	1	20140718
0f446d3d-c9e6-1844-b8e8-a836dc35e0de	Product name	1	20140508
33a4b7b4-a3c1-3f95-a202-01166dd77c44	Product name	1	20140508
60519d27-227d-404a-38bc-37524c8b386b	Product name	1	20140508
d5f30598-8f94-b083-f161-65d67f2ae12a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64370-375-01	2023-04-07	HEMANGEOL® (propranolol hydrochloride oral solution) These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. Initial U.S. Approval: 1967
64370-375-01	2023-04-07	HEMANGEOL® (propranolol hydrochloride oral solution) These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. Initial U.S. Approval: 1967
64370-375-50	2023-04-07	HEMANGEOL® (propranolol hydrochloride oral solution) These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. Initial U.S. Approval: 1967
64370-375-50	2023-04-07	HEMANGEOL® (propranolol hydrochloride oral solution) These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. Initial U.S. Approval: 1967
64370-375-01	2023-01-30	HEMANGEOL® (propranolol hydrochloride oral solution) These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. Initial U.S. Approval: 1967
64370-375-01	2023-01-30	HEMANGEOL® (propranolol hydrochloride oral solution) These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. Initial U.S. Approval: 1967
64370-375-50	2023-01-30	HEMANGEOL® (propranolol hydrochloride oral solution) These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. Initial U.S. Approval: 1967
64370-375-50	2023-01-30	HEMANGEOL® (propranolol hydrochloride oral solution) These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. Initial U.S. Approval: 1967

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64370-375-01	HEMANGEOL	1 in 1 CARTON	SOLUTION	1	20
64370-375-01	HEMANGEOL	120 mL in 1 BOTTLE, GLASS	SOLUTION	120	20
64370-375-50	HEMANGEOL	50 mL in 1 BOTTLE, GLASS	SOLUTION	50	20
64370-375-50	HEMANGEOL	1 in 1 CARTON	SOLUTION	1	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64370-375-01	ML - Milliliter	64370-375	79299d85-bb2a-4d6f-849b-0fa9dae6998e	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PROPRANOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	F8A3652H1V	HEMANGEOL (PROPRANOLOL HYDROCHLORIDE) SOLUTION [PIERRE FABRE PHARMACEUTICALS, INC.]	9
PROPRANOLOL	ACTIVE MOIETY	9Y8NXQ24VQ	HEMANGEOL (PROPRANOLOL HYDROCHLORIDE) SOLUTION [PIERRE FABRE PHARMACEUTICALS, INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64370-375	HEMANGEOL (PROPRANOLOL HYDROCHLORIDE) SOLUTION [PIERRE FABRE PHARMACEUTICALS, INC.]	19	Current NDC, Legacy NDC, 4 package rows	20241108_b6f9dd2a-632b-87eb-70f0-b2064d7ed48a.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 · 2 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 ndc (product): 64370-375
HEMANGEOL	PROPRANOLOL HYDROCHLORIDE	Eton Pharmaceuticals, Inc.	4f8341ee-dac6-1ca9-e063-6394a90ac960	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205410 application number: NDA205410

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F8A3652H1V	PROPRANOLOL HYDROCHLORIDE	318-98-9	PROPRANOLOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1495064	Hemangeol 4.28 MG in 1 mL Oral Solution	PSN	b6f9dd2a-632b-87eb-70f0-b2064d7ed48a	20
1495058	propranolol HCl 4.28 MG in 1 mL Oral Solution	PSN	b6f9dd2a-632b-87eb-70f0-b2064d7ed48a	20
1495064	propranolol hydrochloride 4.28 MG/ML Oral Solution [Hemangeol]	SBD	b6f9dd2a-632b-87eb-70f0-b2064d7ed48a	20
1495058	propranolol hydrochloride 4.28 MG/ML Oral Solution	SCD	b6f9dd2a-632b-87eb-70f0-b2064d7ed48a	20
1495064	Hemangeol 4.28 MG per 1 ML Oral Solution	SY	b6f9dd2a-632b-87eb-70f0-b2064d7ed48a	20
1495064	Hemangeol 4.28 MG/ML (as propranolol 3.75 MG/ML) Oral Solution	SY	b6f9dd2a-632b-87eb-70f0-b2064d7ed48a	20
1495058	propranolol HCl 4.28 MG/ML (as propranolol 3.75 MG/ML) Oral Solution	SY	b6f9dd2a-632b-87eb-70f0-b2064d7ed48a	20
1495058	propranolol hydrochloride 4.28 MG per 1 ML Oral Solution	SY	b6f9dd2a-632b-87eb-70f0-b2064d7ed48a	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64370-375-01	64370037501	1 BOTTLE, GLASS in 1 CARTON (64370-375-01) / 120 mL in 1 BOTTLE, GLASS	2014-04-14	0000-00-00	No	No	Current
64370-375-50	64370037550	1 BOTTLE, GLASS in 1 CARTON (64370-375-50) / 50 mL in 1 BOTTLE, GLASS	2014-04-14	0000-00-00	No	No	Current