Home NDC 25021-673 glydo
Product NDC 25021-673
11-digit product format 250210673
Labeler code 25021
Product ID 25021-673_17e6ad03-b5bc-4930-8db5-e787ef954448
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lidocaine hydrochloride
Dosage form JELLY
Route TOPICAL
Labeler Sagent Pharmaceuticals
Application ANDA201094
Marketing category ANDA
Marketing start 2014-09-15
Substance LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength 20 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 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 A201094-001 GLYDO LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2014-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201094-001 AT
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 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201094-001 GLYDO 2% JELLY / TOPICAL AT RS 2014-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201094-001 GLYDO 2% JELLY / TOPICAL AT 2014-04-28 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 glydo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EC2CNF7XFP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1011852 Internal RxNorm lookup 1549447 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-673 GLYDO (LIDOCAINE HYDROCHLORIDE) JELLY [SAGENT PHARMACEUTICALS] 11 Current NDC, Legacy NDC, 4 package rows 20220728_65760723-75cd-472c-96e1-7d05f95b4686.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25021-673-76 25021067376 10 SYRINGE in 1 CARTON (25021-673-76) / 6 mL in 1 SYRINGE 10 syringe 2014-09-15 0000-00-00 No No Current 25021-673-77 25021067377 10 SYRINGE in 1 CARTON (25021-673-77) / 11 mL in 1 SYRINGE 10 syringe 2014-09-15 0000-00-00 No No Current