Conray

Product NDC: 0019-0953
11-digit product format: 000190953
Labeler code: 0019
Product ID: 0019-0953_0ad12048-60f9-474e-b488-cb152456977f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: iothalamate meglumine
Dosage form: INJECTION
Route: INTRAVASCULAR
Labeler: Liebel-Flarsheim Company LLC
Application: NDA013295
Marketing category: NDA
Marketing start: 2003-10-14
Substance: IOTHALAMATE MEGLUMINE
Active strength: 600 mg/mL
Pharmacologic classes: Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N013295-001	CONRAY	IOTHALAMATE MEGLUMINE	60%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
N013295-002	CONRAY 43	IOTHALAMATE MEGLUMINE	43%	INJECTABLE / INJECTION		RLD, 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 3 · 82 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	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IOTHALAMATE MEGLUMINE	600 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XUW72GOP7W	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1292abfc-496f-4df7-9a08-72072953e1f1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
12862b73-6850-4518-8415-07dc41a94ae3	Product name	1	20140508
62094e4a-03c5-8dd0-8cc1-762d2eb27546	Product name	1	20140508
af8cbdc1-507e-d5b3-315b-c8689d8c5b83	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0019-0953-05	Conray	25 in 1 BOX	INJECTION	25	20
0019-0953-05	Conray	50 mL in 1 VIAL, GLASS	INJECTION	50	20
0019-0953-10	Conray	100 mL in 1 BOTTLE, GLASS	INJECTION	100	20
0019-0953-10	Conray	12 in 1 BOX	INJECTION	12	20
0019-0953-23	Conray	25 in 1 BOX	INJECTION	25	20
0019-0953-23	Conray	30 mL in 1 VIAL, GLASS	INJECTION	30	20
0019-0953-50	Conray	12 in 1 BOX	INJECTION	12	20
0019-0953-50	Conray	150 mL in 1 BOTTLE, GLASS	INJECTION	150	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0019-0953-05	ML - Milliliter	0019-0953	206f9aeb-ce67-4c96-8d48-7b3b8da13b44	1	2017-12-14
0019-0953-09	ML - Milliliter	0019-0953	0dd7e9ac-7188-473d-a11c-d2189743ef9e	1	2012-07-24
0019-0953-11	ML - Milliliter	0019-0953	0e2d6657-613a-473b-9806-93e94a2a0de1	1	2012-07-24
0019-0953-13	ML - Milliliter	0019-0953	3a2ee99b-4369-47e9-a4b1-eb47c51bbc20	1	2012-07-24
0019-0953-15	ML - Milliliter	0019-0953	9985383c-3981-47c9-b030-1b846b3ce718	1	2012-07-24
0019-0953-23	ML - Milliliter	0019-0953	c85117c1-7455-43fe-b5f3-689ad24e2274	1	2019-02-13
0019-0953-50	ML - Milliliter	0019-0953	c3816e24-7969-4a82-949c-184346e3956d	1	2020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IOTHALAMATE MEGLUMINE	ACTIVE INGREDIENT	XUW72GOP7W	CONRAY (IOTHALAMATE MEGLUMINE) INJECTION [MALLINCKRODT INC.]	12
IOTHALAMIC ACID	ACTIVE MOIETY	16CHD79MIX	CONRAY (IOTHALAMATE MEGLUMINE) INJECTION [MALLINCKRODT INC.]	12
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	CONRAY (IOTHALAMATE MEGLUMINE) INJECTION [MALLINCKRODT INC.]	12
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	INACTIVE INGREDIENT	3980JIH2SW	CONRAY (IOTHALAMATE MEGLUMINE) INJECTION [MALLINCKRODT INC.]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0019-0953	CONRAY (IOTHALAMATE MEGLUMINE) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC]	20	Current NDC, Legacy NDC, 8 package rows	20230513_1292abfc-496f-4df7-9a08-72072953e1f1.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
Conray	IOTHALAMATE MEGLUMINE	Liebel-Flarsheim Company LLC	1292abfc-496f-4df7-9a08-72072953e1f1	2023-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 013295 application number: NDA013295 ndc (product): 0019-0953

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XUW72GOP7W	IOTHALAMATE MEGLUMINE	13087-53-1	IOTHALAMATE MEGLUMINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0019-0953-05	00019095305	25 VIAL, GLASS in 1 BOX (0019-0953-05) / 50 mL in 1 VIAL, GLASS	2003-10-14	0000-00-00	No	No	Current
0019-0953-10	00019095310	12 BOTTLE, GLASS in 1 BOX (0019-0953-10) / 100 mL in 1 BOTTLE, GLASS	2003-10-14	0000-00-00	No	No	Current
0019-0953-23	00019095323	25 VIAL, GLASS in 1 BOX (0019-0953-23) / 30 mL in 1 VIAL, GLASS	2003-10-14	0000-00-00	No	No	Current
0019-0953-50	00019095350	12 BOTTLE, GLASS in 1 BOX (0019-0953-50) / 150 mL in 1 BOTTLE, GLASS	2003-10-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
2/2023 Conray ® (Iothalamate Meglumine Injection USP 60%)	Liebel-Flarsheim Company LLC \| Justesa Imagen, S.A.U.	2023-05-11	HUMAN PRESCRIPTION DRUG LABEL	20