Home NDC 67877-767-30 Lidocaine
Product NDC 67877-767
Requested package NDC 67877-767-30
11-digit product format 678770767
Labeler code 67877
Product ID 67877-767_b67e6b6a-0b21-4c7b-958f-4fd3fc58eb49
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine
Dosage form PATCH
Route TOPICAL
Labeler Ascend Laboratories, LLC
Application ANDA216484
Marketing category ANDA
Marketing start 2026-09-22
Substance LIDOCAINE
Active strength 50 mg/g
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 43 .
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 A216484-001 LIDOCAINE LIDOCAINE 5% PATCH / TOPICAL AB 2025-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216484-001 AB
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.
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 A216484-001 LIDOCAINE 5% PATCH / TOPICAL AB 2025-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216484-001 LIDOCAINE 5% PATCH / TOPICAL AB 2025-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216484-001 LIDOCAINE 5% PATCH / TOPICAL AB 2025-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216484-001 LIDOCAINE 5% PATCH / TOPICAL AB 2025-10-06 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216484-001 LIDOCAINE 5% PATCH / TOPICAL AB 2025-10-06 a50c72e98297…
Observed Orange Book normalized TE history# 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 Lidocaine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 50 mg/g
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67877-767-30 67877076730 30 POUCH in 1 CARTON (67877-767-30) / 1 g in 1 POUCH (67877-767-14) 30 pouch 2026-09-22 No No Current