Indigo Carmine

Product NDC: 0517-0375
11-digit product format: 005170375
Labeler code: 0517
Product ID: 0517-0375_bedc5a88-2a85-4655-b48e-4121cd271c4c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indigo Carmine
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: American Regent, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: INDIGOTINDISULFONATE SODIUM
Active strength: 8 mg/mL
Pharmacologic classes: Diagnostic Dye [EPC], Dyes [MoA]
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	0517-0375		D	Discontinued by firm		2026-08-17
excluded package	package	0517-0375	0517-0375-05	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0517-0375-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0517-0375-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0517-0375-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0517-0375-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0517-0375-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0517-0375-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0517-0375-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0517-0375-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0517-0375-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0517-0375-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0517-0375-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0517-0375-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-0375-01	ML - Milliliter	0517-0375	b25ac3f4-767c-4ad7-ab99-36db1082666c	1	2017-07-07
0517-0375-05	ML - Milliliter	0517-0375	48b981e8-cd8f-4ae8-9fd5-3ddec0c4f3ce	1	2017-07-07
0517-0375-10	ML - Milliliter	0517-0375	a732d195-c537-46fe-823a-7e41505f9537	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDIGOTINDISULFONATE SODIUM	ACTIVE INGREDIENT	D3741U8K7L	INDIGO CARMINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	2
INDIGOTINDISULFONIC ACID	ACTIVE MOIETY	X7OI7JF73P	INDIGO CARMINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	INDIGO CARMINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	INDIGO CARMINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	INDIGO CARMINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D3741U8K7L	INDIGOTINDISULFONATE SODIUM	860-22-0	INDIGOTINDISULFONATE SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-0375-05	00517037505	5 AMPULE in 1 BOX (0517-0375-05) > 1 mL in 1 AMPULE (0517-0375-01)	5 ampule	1990-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INDIGO CARMINE INJECTION (Indigotindisulfonate Sodium Injection, USP)	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	3
INDIGO CARMINE INJECTION (Indigotindisulfonate Sodium Injection, USP)	American Regent, Inc.	2019-12-06	HUMAN PRESCRIPTION DRUG LABEL	6