Home NDC 0115-1468-60 Lidocaine and Prilocaine
Product NDC 0115-1468
Requested package NDC 0115-1468-60
11-digit product format 001151468
Labeler code 0115
Product ID 0115-1468_ef0e52f0-eafb-4ccc-86f4-19672a142b3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine and Prilocaine
Dosage form CREAM
Route TOPICAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA076320
Marketing category ANDA
Marketing start 2003-08-27
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A076320-001 LIDOCAINE AND PRILOCAINE LIDOCAINE; PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076320-001 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.
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 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LIDOCAINE ACTIVE INGREDIENT 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 PRILOCAINE ACTIVE INGREDIENT 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 PRILOCAINE ACTIVE MOIETY 046O35D44R LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 CARBOMER HOMOPOLYMER TYPE B INACTIVE INGREDIENT HHT01ZNK31 LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 POLYOXYL 60 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT 02NG325BQG LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE AND PRILOCAINE CREAM [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1
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 0115-1468-60 00115146860 5 TUBE in 1 CARTON (0115-1468-60) > 5 g in 1 TUBE 5 tube 2003-08-27 0000-00-00 No No Current