Phenylephrine Hydrochloride

Product NDC: 70518-1038
11-digit product format: 705181038
Labeler code: 70518
Product ID: 70518-1038_67d82165-bebb-3a80-e053-2991aa0abb84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenylephrine Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: REMEDYREPACK INC.
Application: NDA203826
Marketing category: NDA
Marketing start: 2018-03-01
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10 mg/mL
Pharmacologic classes: alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-1038		D	Discontinued by firm	2026-08-03
excluded package	package	70518-1038	70518-1038-0	D	Discontinued by firm	2026-08-03
excluded package	package	70518-1038	70518-1038-1	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1038-0	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1038-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1038-0	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1038-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1038-0	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1038-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1038-0	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1038-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1038-0	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1038-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1038-0	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1038-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1038-0	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1038-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1038-0	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1038-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1038-0	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1038-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1038-0	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1038-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-1038-0	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-1038-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-1038-0	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-1038-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	70518-1038-0	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	70518-1038-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	70518-1038-0	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	70518-1038-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203826-001	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20
N203826-002	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2019-06-19
N203826-003	PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2019-06-19
N203826-004	IMMPHENTIV	PHENYLEPHRINE HYDROCHLORIDE	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09
N203826-005	IMMPHENTIV	PHENYLEPHRINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N203826-001	AP2
N203826-002	AP2
N203826-003	AP2

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N203826-004	11471400	2036-08-05	Drug product	2023-03-22
N203826-004	11213480	2036-09-26	Drug product	2023-03-22
N203826-004	12257342	2036-09-26	Drug product	2025-04-23
N203826-005	11471400	2036-08-05	Drug product	2023-03-22
N203826-005	11213480	2036-09-26	Drug product	2023-03-22
N203826-005	12257342	2036-09-26	Drug product	2025-04-23

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 5 · 167 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
2026-02-19 14:30 UTC	2026-02	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2019-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2019-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2019-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2019-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-001	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2012-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-002	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-003	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-004	IMMPHENTIV	0.5MG/5ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-005	IMMPHENTIV	1MG/10ML (0.1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-03-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 85 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203826-001	AP2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-002	AP2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-003	AP2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-001	AP2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-002	AP2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-003	AP2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203826-001	AP2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-001	AP2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-001	AP2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-001	AP2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-001	AP2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-001	AP2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203826-001	AP2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203826-001	AP2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203826-001	AP2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203826-001	AP2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203826-001	AP2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203826-001	AP2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203826-001	AP2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203826-002	AP2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203826-003	AP2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203826-001	AP2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203826-002	AP2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203826-003	AP2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203826-001	AP2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203826-002	AP2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203826-003	AP2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203826-001	AP2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203826-002	AP2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203826-003	AP2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203826-001	AP2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203826-002	AP2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203826-003	AP2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203826-001	AP2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203826-002	AP2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203826-003	AP2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203826-001	AP2	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203826-002	AP2	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203826-003	AP2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203826-001	AP2	1	`5aa47cf7b7d7…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-004	12257342	2036-09-26	Drug product	2025-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203826-005	12257342	2036-09-26	Drug product	2025-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-004	12257342	2036-09-26	Drug product	2025-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203826-005	12257342	2036-09-26	Drug product	2025-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-004	12257342	2036-09-26	Drug product	2025-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203826-005	12257342	2036-09-26	Drug product	2025-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-005	11471400	2036-08-05	Drug product	2023-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203826-005	11213480	2036-09-26	Drug product	2023-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203826-004	11471400	2036-08-05	Drug product	2023-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203826-004	11213480	2036-09-26	Drug product	2023-03-22	`d8e5a09893c0…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70518-1038-0	2021-04-28	These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE. PHENYLEPHRINE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2012
70518-1038-1	2021-04-28	These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE. PHENYLEPHRINE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2012
70518-1038-0	2020-01-31	These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE. PHENYLEPHRINE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2012
70518-1038-1	2020-01-31	These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE. PHENYLEPHRINE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2012

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Civica, Inc.	7a23ed28-3912-4398-b660-bf9ec3ee3926	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203826 application number: NDA203826
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	c3f358dd-4a36-4808-9943-e01f88604be5	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203826 application number: NDA203826
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203826 application number: NDA203826
PHENYLEPHRINE HCI	PHENYLEPHRINE HCI	HF Acquisition Co LLC, DBA HealthFirst	7602fb73-3ce3-5978-e053-2991aa0abea3	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203826 application number: NDA203826
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	d88a01c4-9681-2695-e053-2995a90a62ea	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203826 application number: NDA203826