Dexamethasone

Product NDC: 10135-795
11-digit product format: 101350795
Labeler code: 10135
Product ID: 10135-795_59cae836-8f84-4276-9289-73ae101b8ddf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: ELIXIR
Route: ORAL
Labeler: Marlex Pharmaceuticals, Inc
Application: ANDA084754
Marketing category: ANDA
Marketing start: 1976-09-21
Substance: DEXAMETHASONE
Active strength: .5 mg/5mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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
A084754-001	DEXAMETHASONE	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	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
A084754-001	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	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084754-001	DEXAMETHASONE	0.5MG/5ML	ELIXIR / ORAL	AA	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	A084754-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084754-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084754-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084754-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084754-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084754-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084754-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084754-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084754-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084754-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084754-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084754-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084754-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084754-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084754-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084754-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084754-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084754-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084754-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084754-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084754-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084754-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084754-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084754-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084754-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084754-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084754-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084754-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084754-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084754-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084754-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084754-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084754-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084754-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084754-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084754-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084754-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084754-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084754-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084754-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXAMETHASONE	.5 mg/5mL

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
309686	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
7b51ffce-ec64-4b49-8870-b9666537c541	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
399647c0-db89-02d1-991c-0c17b584482c	Product name	1	20140508
3e9a6377-704f-dff7-b19f-56c98d40c444	Product name	1	20140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-795-71	Dexamethasone	237 mL in 1 BOTTLE, GLASS	ELIXIR	237		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-795	DEXAMETHASONE ELIXIR [MARLEX PHARMACEUTICALS, INC]	1	Current NDC, 1 package rows	20250504_7b51ffce-ec64-4b49-8870-b9666537c541.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXAMETHASONE	DEXAMETHASONE	Bryant Ranch Prepack	075717e3-be2a-4bb3-bead-492761bfb287	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084754 application number: ANDA084754
Dexamethasone	DEXAMETHASONE	ANI Pharmaceuticals, Inc.	5d9b22ca-c619-4ee3-98eb-74544d0d5cb3	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084754 application number: ANDA084754
Dexamethasone	DEXAMETHASONE	Kesin Pharma Corporation	43e2a24a-4465-5787-e063-6394a90a0b81	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084754 application number: ANDA084754
DEXAMETHASONE	DEXAMETHASONE	Kanchan Healthcare Inc	02f7bf9c-1aa3-4734-8a3e-1f49498055d7	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084754 application number: ANDA084754
Dexamethasone	DEXAMETHASONE	Marlex Pharmaceuticals, Inc	7b51ffce-ec64-4b49-8870-b9666537c541	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084754 application number: ANDA084754 ndc (product): 10135-795

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309686	dexAMETHasone 0.5 MG in 5 mL Oral Solution	PSN	7b51ffce-ec64-4b49-8870-b9666537c541	1
309686	dexamethasone 0.1 MG/ML Oral Solution	SCD	7b51ffce-ec64-4b49-8870-b9666537c541	1
309686	dexamethasone 0.5 MG per 5 ML Oral Solution	SY	7b51ffce-ec64-4b49-8870-b9666537c541	1
309686	dexamethasone 1 MG per 10 ML Oral Solution	SY	7b51ffce-ec64-4b49-8870-b9666537c541	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10135-795-71	10135079571	237 mL in 1 BOTTLE, GLASS (10135-795-71)	237 ml	1976-09-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXAMETHASONE ELIXIR, USP 0.5 mg / 5 mL	Marlex Pharmaceuticals, Inc \| Kanchan healthcare Inc.	2025-04-22	HUMAN PRESCRIPTION DRUG LABEL	1