Dexamethasone Intensol

Product NDC: 85766-264
11-digit product format: 857660264
Labeler code: 85766
Product ID: 85766-264_5987bb27-7262-c69e-e063-6394a90ac820
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone Intensol
Dosage form: SOLUTION, CONCENTRATE
Route: ORAL
Labeler: Sportpharm LLC
Application: ANDA088252
Marketing category: ANDA
Marketing start: 1983-09-01
Substance: DEXAMETHASONE
Active strength: 1 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A088252-001	DEXAMETHASONE INTENSOL	DEXAMETHASONE	1MG/ML	CONCENTRATE / ORAL		RLD, RS	1983-09-01

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RLD, RS	1983-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RLD, RS	1983-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RLD, RS	1983-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Dexamethasone Intensol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXAMETHASONE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7S5I7G3JQL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309684	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
77429dd3-e66d-4ab4-a3f3-5ae0b987ac17	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Intensol	DEXAMETHASONE INTENSOL	Sportpharm LLC	77429dd3-e66d-4ab4-a3f3-5ae0b987ac17	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088252 application number: ANDA088252 ndc (product): 85766-264
Dexamethasone Intensol	DEXAMETHASONE INTENSOL	Hikma Pharmaceuticals USA, Inc.	b15200fb-1826-472b-a907-e677a272513b	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088252 application number: ANDA088252

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85766-264-30	85766026430	30 mL in 1 BOTTLE, GLASS (85766-264-30)	30 ml	2026-08-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexamethasone Oral Solution, USP Intensol ™ (Concentrate)	Sportpharm LLC	2026-08-21	HUMAN PRESCRIPTION DRUG LABEL	1