Dexamethasone

Product NDC: 63629-7806
11-digit product format: 636297806
Labeler code: 63629
Product ID: 63629-7806_4a25abaa-862a-43f7-a3cc-4cfb056e6743
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA088316
Marketing category: ANDA
Marketing start: 1983-09-15
Substance: DEXAMETHASONE
Active strength: 6 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 63629-7806_4a25abaa-862a-43f7-a3cc-4cfb056e6743
SPL ID: 4a25abaa-862a-43f7-a3cc-4cfb056e6743
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Dexamethasone
Generic name: Dexamethasone
Dosage form: TABLET
Route: ORAL
Marketing start: 1983-09-15
Marketing category: ANDA
Application number: ANDA088316
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
DEXAMETHASONE	6 mg/1

Package NDC	Description	Marketing start	Sample
63629-7806-1	30 TABLET in 1 BOTTLE (63629-7806-1)	2018-09-25	No
63629-7806-2	4 TABLET in 1 BOTTLE (63629-7806-2)	2018-09-25	No

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

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63629-7806-1	63629780601	30 TABLET in 1 BOTTLE (63629-7806-1)	30 tablet	2018-09-25	No	No	Historical
63629-7806-2	63629780602	4 TABLET in 1 BOTTLE (63629-7806-2)	4 tablet	2018-09-25	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Dexamethasone Tablets USP, Dexamethasone Oral Solution USP and Dexamethasone Oral Solution USP Intensol ™ (Concentrate)	Bryant Ranch Prepack	2020-09-17	HUMAN PRESCRIPTION DRUG LABEL	1020