Home NDC 71335-3010 Dexamethasone
Product NDC 71335-3010
11-digit product format 713353010
Labeler code 71335
Product ID 71335-3010_320ac974-e60b-475f-afc7-9a52746e45c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA217695
Marketing category ANDA
Marketing start 2023-12-05
Substance DEXAMETHASONE
Active strength 1.5 mg/1
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 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217695-001 DEXAMETHASONE DEXAMETHASONE 0.5MG TABLET / ORAL AB 2023-08-23 A217695-002 DEXAMETHASONE DEXAMETHASONE 0.75MG TABLET / ORAL AB 2023-08-23 A217695-003 DEXAMETHASONE DEXAMETHASONE 1MG TABLET / ORAL AB 2023-08-23 A217695-004 DEXAMETHASONE DEXAMETHASONE 1.5MG TABLET / ORAL AB 2023-08-23 A217695-005 DEXAMETHASONE DEXAMETHASONE 2MG TABLET / ORAL AB 2023-08-23 A217695-006 DEXAMETHASONE DEXAMETHASONE 4MG TABLET / ORAL AB 2023-08-23 A217695-007 DEXAMETHASONE DEXAMETHASONE 6MG TABLET / ORAL AB 2023-08-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 matching rows.
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 4 · 154 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A217695-001 DEXAMETHASONE 0.5MG TABLET / ORAL AB 2023-08-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217695-002 DEXAMETHASONE 0.75MG TABLET / ORAL AB 2023-08-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217695-003 DEXAMETHASONE 1MG TABLET / ORAL AB 2023-08-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217695-004 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2023-08-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217695-005 DEXAMETHASONE 2MG TABLET / ORAL AB 2023-08-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217695-006 DEXAMETHASONE 4MG TABLET / ORAL AB 2023-08-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217695-007 DEXAMETHASONE 6MG TABLET / ORAL AB 2023-08-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217695-001 DEXAMETHASONE 0.5MG TABLET / ORAL AB 2023-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217695-002 DEXAMETHASONE 0.75MG TABLET / ORAL AB 2023-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217695-003 DEXAMETHASONE 1MG TABLET / ORAL AB 2023-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217695-004 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2023-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217695-005 DEXAMETHASONE 2MG TABLET / ORAL AB 2023-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217695-006 DEXAMETHASONE 4MG TABLET / ORAL AB 2023-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217695-007 DEXAMETHASONE 6MG TABLET / ORAL AB 2023-08-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217695-001 DEXAMETHASONE 0.5MG TABLET / ORAL AB 2023-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217695-002 DEXAMETHASONE 0.75MG TABLET / ORAL AB 2023-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217695-003 DEXAMETHASONE 1MG TABLET / ORAL AB 2023-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217695-004 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2023-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217695-005 DEXAMETHASONE 2MG TABLET / ORAL AB 2023-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217695-006 DEXAMETHASONE 4MG TABLET / ORAL AB 2023-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217695-007 DEXAMETHASONE 6MG TABLET / ORAL AB 2023-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217695-001 DEXAMETHASONE 0.5MG TABLET / ORAL AB 2023-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217695-002 DEXAMETHASONE 0.75MG TABLET / ORAL AB 2023-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217695-003 DEXAMETHASONE 1MG TABLET / ORAL AB 2023-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217695-004 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2023-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217695-005 DEXAMETHASONE 2MG TABLET / ORAL AB 2023-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217695-006 DEXAMETHASONE 4MG TABLET / ORAL AB 2023-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217695-007 DEXAMETHASONE 6MG TABLET / ORAL AB 2023-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217695-001 DEXAMETHASONE 0.5MG TABLET / ORAL AB 2023-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217695-002 DEXAMETHASONE 0.75MG TABLET / ORAL AB 2023-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217695-003 DEXAMETHASONE 1MG TABLET / ORAL AB 2023-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217695-004 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2023-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217695-005 DEXAMETHASONE 2MG TABLET / ORAL AB 2023-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217695-006 DEXAMETHASONE 4MG TABLET / ORAL AB 2023-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217695-007 DEXAMETHASONE 6MG TABLET / ORAL AB 2023-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217695-001 DEXAMETHASONE 0.5MG TABLET / ORAL AB 2023-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217695-002 DEXAMETHASONE 0.75MG TABLET / ORAL AB 2023-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217695-003 DEXAMETHASONE 1MG TABLET / ORAL AB 2023-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217695-004 DEXAMETHASONE 1.5MG TABLET / ORAL AB 2023-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217695-005 DEXAMETHASONE 2MG TABLET / ORAL AB 2023-08-23 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 154 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217695-003 CGT 2024-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217695-003 CGT 2024-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217695-003 CGT 2024-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217695-003 CGT 2024-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217695-003 CGT 2024-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217695-003 CGT 2024-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217695-003 CGT 2024-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217695-003 CGT 2024-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217695-003 CGT 2024-04-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217695-003 CGT 2024-04-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217695-003 CGT 2024-04-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217695-003 CGT 2024-04-29 ea1830bbd6c7…
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXAMETHASONE 1.5 mg/1
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 197580 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# 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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-3010-1 71335301001 35 TABLET in 1 BOTTLE (71335-3010-1) 35 tablet 2026-02-04 No No Current 71335-3010-2 71335301002 21 TABLET in 1 BOTTLE (71335-3010-2) 21 tablet 2026-02-04 No No Current 71335-3010-3 71335301003 51 TABLET in 1 BOTTLE (71335-3010-3) 51 tablet 2026-02-04 No No Current 71335-3010-4 71335301004 90 TABLET in 1 BOTTLE (71335-3010-4) 90 tablet 2026-02-04 No No Current 71335-3010-5 71335301005 120 TABLET in 1 BOTTLE (71335-3010-5) 120 tablet 2026-02-04 No No Current 71335-3010-6 71335301006 100 TABLET in 1 BOTTLE (71335-3010-6) 100 tablet 2026-02-04 No No Current 71335-3010-7 71335301007 55 TABLET in 1 BOTTLE (71335-3010-7) 55 tablet 2026-02-04 No No Current 71335-3010-8 71335301008 10 TABLET in 1 BOTTLE (71335-3010-8) 10 tablet 2026-02-04 No No Current