Phospholine Iodide

Product NDC: 0046-1065
Requested package NDC: 0046-1065-05
11-digit product format: 000461065
Labeler code: 0046
Product ID: 0046-1065_d6430e45-82f7-41b6-8db8-4d6f486303f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: echothiophate iodide
Dosage form: KIT
Labeler: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application: NDA011963
Marketing category: NDA
Marketing start: 1959-12-04
Marketing end: 2022-06-30
Active strength: 0
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0046-1065	0046-1065-05	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N011963-001	PHOSPHOLINE IODIDE	ECHOTHIOPHATE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982
N011963-002	PHOSPHOLINE IODIDE	ECHOTHIOPHATE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982
N011963-003	PHOSPHOLINE IODIDE	ECHOTHIOPHATE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982
N011963-004	PHOSPHOLINE IODIDE	ECHOTHIOPHATE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011963-001	PHOSPHOLINE IODIDE	0.125%	FOR SOLUTION / OPHTHALMIC	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011963-002	PHOSPHOLINE IODIDE	0.03%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011963-003	PHOSPHOLINE IODIDE	0.25%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011963-004	PHOSPHOLINE IODIDE	0.06%	FOR SOLUTION / OPHTHALMIC	Approved before 1982	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0046-1065-05	ML - Milliliter	0046-1065	1c205c72-bfea-42a8-ab7e-3accf5b8f071	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ECHOTHIOPHATE IODIDE	ACTIVE INGREDIENT	BA9QH3P00T	PHOSPHOLINE IODIDE OPHTHALMIC (ECHOTHIOPHATE IODIDE) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	3
ECHOTHIOPHATE	ACTIVE MOIETY	0F350BVT6S	PHOSPHOLINE IODIDE OPHTHALMIC (ECHOTHIOPHATE IODIDE) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	3
POTASSIUM ACETATE	INACTIVE INGREDIENT	M911911U02	PHOSPHOLINE IODIDE OPHTHALMIC (ECHOTHIOPHATE IODIDE) KIT [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	3

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
Phospholine Iodide	ECHOTHIOPHATE IODIDE FOR OPHTHALMIC SOLUTION	Fera Pharmaceuticals, LLC	8afc8951-db76-4f27-8752-7c0d6aa47244	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011963 application number: NDA011963

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BA9QH3P00T	ECHOTHIOPHATE IODIDE	513-10-0	echothiophate iodide

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0046-1065-05	00046106505	1 KIT in 1 KIT (0046-1065-05) * 6.25 mL in 1 BOTTLE (0046-1465-05) * 5 mL in 1 BOTTLE (0046-1162-05)	1 kit	1959-12-04	2022-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phospholine Iodide ® (echothiophate iodide for ophthalmic solution)	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	2021-08-10	HUMAN PRESCRIPTION DRUG LABEL	12