Biorphen

Product NDC: 71863-208
11-digit product format: 718630208
Labeler code: 71863
Product ID: 71863-208_3508aaf0-b0e3-4aeb-909d-83c13c30a30f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenylephrine hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Eton Pharmaceuticals, Inc.
Application: NDA212909
Marketing category: NDA
Marketing start: 2019-11-15
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 0 mg/mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71863-208		I	Inactivated by FDA		2026-08-17
excluded package	package	71863-208	71863-208-05	I	Inactivated by FDA		2026-08-17

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
N212909-001	BIORPHEN	PHENYLEPHRINE HYDROCHLORIDE	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-10-21
N212909-002	BIORPHEN	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N212909-001	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 · 75 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	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N212909-001	BIORPHEN	0.1MG/ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212909-002	BIORPHEN	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2021-03-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212909-001	BIORPHEN	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-21	`782e0a99824c…`

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	N212909-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212909-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212909-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212909-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212909-001	AP	1	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212909-001	AP	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71863-208-05	Biorphen	5 mL in 1 VIAL	INJECTION, SOLUTION	5		11
71863-208-05	Biorphen	1 in 1 CARTON	INJECTION, SOLUTION	1		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71863-208	BIORPHEN (PHENYLEPHRINE HYDROCHLORIDE) INJECTION, SOLUTION [ETON PHARMACEUTICALS, INC.]	11	Legacy NDC, 2 package rows	20220831_bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biorphen	PHENYLEPHRINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	2f715e4e-b269-b935-d2c9-003cb29770be	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212909 application number: NDA212909

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2533437	Biorphen 10 MG in 1 ML Injection	PSN	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11
2533434	Biorphen 500 MCG in 5 mL Injection	PSN	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11
1666372	phenylephrine HCl 10 MG in 1 ML Injection	PSN	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11
2262018	phenylephrine hydrochloride 500 MCG in 5 mL Injection	PSN	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11
2533437	1 ML phenylephrine hydrochloride 10 MG/ML Injection [Biorphen]	SBD	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11
2533434	5 ML phenylephrine hydrochloride 0.1 MG/ML Injection [Biorphen]	SBD	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11
1666372	1 ML phenylephrine hydrochloride 10 MG/ML Injection	SCD	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11
2262018	5 ML phenylephrine hydrochloride 0.1 MG/ML Injection	SCD	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11
2533434	Biorphen 0.1 MG/ML per 5 ML Injection	SY	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11
2533437	Biorphen 10 MG per 1 ML Injection	SY	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11
2533434	Biorphen 500 MCG per 5 ML Injection	SY	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11
1666372	phenylephrine HCl 10 MG per 1 ML Injection	SY	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11
2262018	phenylephrine hydrochloride 500 MCG per 5 ML Injection	SY	bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71863-208-05	71863020805	1 VIAL in 1 CARTON (71863-208-05) > 5 mL in 1 VIAL	1 vial	2022-03-25	0000-00-00	No	No	Current