Home NDC 52565-007-30 Lidocaine and Prilocaine
Product NDC 52565-007
Requested package NDC 52565-007-30
11-digit product format 525650007
Labeler code 52565
Product ID 52565-007_de4a6eae-ba69-4f23-9cb1-9a827cbdbd6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine and Prilocaine
Dosage form CREAM
Route TOPICAL
Labeler Teligent Pharma, Inc.
Application ANDA205887
Marketing category ANDA
Marketing start 2018-06-29
Marketing end 0000-00-00
Substance LIDOCAINE; PRILOCAINE
Active strength 25 mg/g; mg/g
Pharmacologic classes Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A205887-001 LIDOCAINE AND PRILOCAINE LIDOCAINE; PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2018-06-29
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 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2018-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2018-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2018-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2018-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2018-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2018-06-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2018-06-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2018-06-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2018-06-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2018-06-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205887-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2018-06-29 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52565-007-07 Lidocaine and Prilocaine 5 in 1 CARTON CREAM 5 3 52565-007-07 Lidocaine and Prilocaine 5 g in 1 TUBE CREAM 5 3 52565-007-30 Lidocaine and Prilocaine 1 in 1 CARTON CREAM 1 3 52565-007-30 Lidocaine and Prilocaine 30 g in 1 TUBE CREAM 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52565-007 LIDOCAINE AND PRILOCAINE CREAM [TELIGENT PHARMA, INC.] 3 Legacy NDC, 4 package rows 20181121_7a790e8b-ff12-411f-bacc-9141d4dfef58.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 Marketing end Sample Exclude flag Status 52565-007-30 52565000730 1 TUBE in 1 CARTON (52565-007-30) > 30 g in 1 TUBE 1 tube 2018-06-29 0000-00-00 No No Current