Home NDC 63629-2504 Lidocaine
Product NDC 63629-2504
11-digit product format 636292504
Labeler code 63629
Product ID 63629-2504_2811ddc3-8d09-469e-922f-c9cebeaa31af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine
Dosage form OINTMENT
Route TOPICAL
Labeler Bryant Ranch Prepack
Application ANDA207810
Marketing category ANDA
Marketing start 2017-03-10
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 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 A207810-001 LIDOCAINE LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207810-001 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 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207810-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-03-10 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 Lidocaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1543069 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-2504-1 Lidocaine 35.44 g in 1 TUBE OINTMENT 35.44 102 63629-2504-1 Lidocaine 1 in 1 CARTON OINTMENT 1 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2504 LIDOCAINE OINTMENT [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 2 package rows 20230222_da9707e2-f830-45e2-a300-1f99cf3dd362.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 · 5 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 63629-2504-1 63629250401 1 TUBE in 1 CARTON (63629-2504-1) / 35.44 g in 1 TUBE 1 tube 2021-03-09 0000-00-00 No No Current