Phospholine Iodide

Product NDC: 48102-053
11-digit product format: 481020053
Labeler code: 48102
Product ID: 48102-053_66abcfcf-b16e-4181-b1db-96bfba0ab95e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: echothiophate iodide for ophthalmic solution
Dosage form: KIT
Route: OPHTHALMIC
Labeler: Fera Pharmaceuticals, LLC
Application: NDA011963
Marketing category: NDA
Marketing start: 2022-06-01
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Phospholine Iodide
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205739	Internal RxNorm lookup
310049	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
8afc8951-db76-4f27-8752-7c0d6aa47244	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
54d38512-5b7a-d254-ef1b-3c043e7acd6a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48102-053-05	Phospholine Iodide	1 in 1 CARTON	KIT	1		5
48102-054-05	Phospholine Iodide	6.25 mL in 1 BOTTLE	POWDER, FOR SOLUTION	6.25 mL	6.25 mg in 5mL	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
48102-053-05	ML - Milliliter	48102-053	70b4f94e-1087-461b-9fdf-6c5737986a08	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
48102-053	PHOSPHOLINE IODIDE (ECHOTHIOPHATE IODIDE FOR OPHTHALMIC SOLUTION) KIT [FERA PHARMACEUTICALS, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20240913_8afc8951-db76-4f27-8752-7c0d6aa47244.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
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 ndc (product): 48102-053

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310049	echothiophate iodide 0.125 % Ophthalmic Solution	PSN	8afc8951-db76-4f27-8752-7c0d6aa47244	5
205739	Phospholine Iodide 0.125 % Ophthalmic Solution	PSN	8afc8951-db76-4f27-8752-7c0d6aa47244	5
205739	echothiophate iodide 1.25 MG/ML Ophthalmic Solution [Phospholine Iodide]	SBD	8afc8951-db76-4f27-8752-7c0d6aa47244	5
310049	echothiophate iodide 1.25 MG/ML Ophthalmic Solution	SCD	8afc8951-db76-4f27-8752-7c0d6aa47244	5
310049	echothiophate iodide 0.125 % Ophthalmic Solution	SY	8afc8951-db76-4f27-8752-7c0d6aa47244	5
205739	Phospholine Iodide 0.125 % Ophthalmic Solution	SY	8afc8951-db76-4f27-8752-7c0d6aa47244	5
205739	Phospholine Iodide 1.25 MG/ML Ophthalmic Solution	SY	8afc8951-db76-4f27-8752-7c0d6aa47244	5
205739	Phospholine Iodide 6.25 MG per 5 ML Ophthalmic Solution	SY	8afc8951-db76-4f27-8752-7c0d6aa47244	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
48102-053-05	48102005305	1 KIT in 1 CARTON (48102-053-05) * 6.25 mL in 1 BOTTLE (48102-054-05) * 5 mL in 1 BOTTLE (48102-055-05)	1 kit	2022-06-01	0000-00-00	No	No	Current
48102-054-05	48102005405	6.25 mL in 1 BOTTLE	6.25 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phospholine Iodide® (echothiophate iodide for ophthalmic solution)	Fera Pharmaceuticals, LLC	2025-07-07	HUMAN PRESCRIPTION DRUG LABEL	5