Home NDC 62135-114 Dexamethasone
Product NDC 62135-114
11-digit product format 621350114
Labeler code 62135
Product ID 62135-114_13a14c37-eaf1-7848-e063-6394a90a5479
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form ELIXIR
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA091188
Marketing category ANDA
Marketing start 2011-05-11
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 A091188-001 DEXAMETHASONE DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091188-001 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 Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091188-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-05-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-114-37 Dexamethasone 237 mL in 1 BOTTLE ELIXIR 237 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-114 DEXAMETHASONE ELIXIR [CHARTWELL RX, LLC] 2 Current NDC, 1 package rows 20240316_3746066a-3c87-4238-945a-6dfb4d01a072.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-114-37 62135011437 237 mL in 1 BOTTLE (62135-114-37) 237 ml 2023-01-13 No No Current