Gastrografin

Product NDC: 0270-0445
11-digit product format: 002700445
Labeler code: 0270
Product ID: 0270-0445_7c17ff73-033f-4c13-b31d-3f84a9f88768
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diatrizoate meglumine and diatrizoate sodium
Dosage form: LIQUID
Route: ORAL; RECTAL
Labeler: Bracco Diagnostics Inc
Application: NDA011245
Marketing category: NDA
Marketing start: 1958-02-26
Substance: DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Active strength: 660; 100 mg/mL; mg/mL
Pharmacologic classes: Radiographic Contrast Agent [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA], 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N011245-003	GASTROGRAFIN	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N011245-003	AA

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011245-003	GASTROGRAFIN	66%;10%	SOLUTION / ORAL, RECTAL	AA	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N011245-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011245-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011245-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011245-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011245-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011245-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011245-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011245-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011245-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011245-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011245-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011245-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011245-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011245-003	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011245-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011245-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011245-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011245-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011245-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011245-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011245-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011245-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011245-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011245-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011245-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011245-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011245-003	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011245-003	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N011245-003	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N011245-003	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011245-003	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011245-003	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011245-003	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011245-003	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011245-003	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011245-003	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011245-003	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N011245-003	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N011245-003	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011245-003	AA	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIATRIZOATE MEGLUMINE	660 mg/mL
DIATRIZOATE SODIUM	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3X9MR4N98U	Internal UNII lookup
V5403H8VG7	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
8c2340e4-2b42-45dc-8fac-9960e8172547	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a8f1679b-19b1-407c-9ee3-d33055bee6fc	Product name	2	20250731
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0270-0445-35	Gastrografin	24 in 1 BOX	LIQUID	24	8
0270-0445-35	Gastrografin	30 mL in 1 BOTTLE	LIQUID	30	8
0270-0445-40	Gastrografin	120 mL in 1 BOTTLE	LIQUID	120	8
0270-0445-40	Gastrografin	12 in 1 BOX	LIQUID	12	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0270-0445-35	ML - Milliliter	0270-0445	dbe2ba48-7d1c-44da-b913-5e6d22c4d529	1	2012-07-24
0270-0445-40	ML - Milliliter	0270-0445	cb902fc1-6290-43ed-9204-622bef0497e9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
diatrizoate meglumine	ACTIVE INGREDIENT	3X9MR4N98U	GASTROGRAFIN (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM) LIQUID [BRACCO DIAGNOSTICS INC]	4
diatrizoate sodium	ACTIVE INGREDIENT	V5403H8VG7	GASTROGRAFIN (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM) LIQUID [BRACCO DIAGNOSTICS INC]	4
DIATRIZOIC ACID	ACTIVE MOIETY	5UVC90J1LK	GASTROGRAFIN (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM) LIQUID [BRACCO DIAGNOSTICS INC]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	GASTROGRAFIN (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM) LIQUID [BRACCO DIAGNOSTICS INC]	4
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	GASTROGRAFIN (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM) LIQUID [BRACCO DIAGNOSTICS INC]	4
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	GASTROGRAFIN (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM) LIQUID [BRACCO DIAGNOSTICS INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0270-0445	GASTROGRAFIN (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM) LIQUID [BRACCO DIAGNOSTICS INC]	8	Current NDC, Legacy NDC, 4 package rows	20211013_8c2340e4-2b42-45dc-8fac-9960e8172547.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
Gastrografin	DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM	Bracco Diagnostics Inc	8c2340e4-2b42-45dc-8fac-9960e8172547	2021-10-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011245 application number: NDA011245 ndc (product): 0270-0445

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X9MR4N98U	DIATRIZOATE MEGLUMINE	131-49-7	DIATRIZOATE MEGLUMINE
V5403H8VG7	DIATRIZOATE SODIUM	737-31-5	DIATRIZOATE SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0270-0445-35	00270044535	24 BOTTLE in 1 BOX (0270-0445-35) / 30 mL in 1 BOTTLE	24 bottle	2005-04-01	0000-00-00	No	No	Current
0270-0445-40	00270044540	12 BOTTLE in 1 BOX (0270-0445-40) / 120 mL in 1 BOTTLE	12 bottle	1958-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GASTROGRAFIN ® Diatrizoate Meglumine and Diatrizoate Sodium Solution USP	Bracco Diagnostics Inc \| E-Z-EM Canada Inc \| Justesa Imagen, S.A.U \| Merck SL	2021-10-04	HUMAN PRESCRIPTION DRUG LABEL	8