Home NDC 0115-1468 Lidocaine and Prilocaine
Product NDC 0115-1468
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076320-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-27 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A076320-001 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076320-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076320-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A076320-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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 0115-1468-45 00115146845 1 TUBE in 1 CARTON (0115-1468-45) > 30 g in 1 TUBE 1 tube 2003-08-27 0000-00-00 No No Current 0115-1468-53 00115146853 1 TUBE in 1 CARTON (0115-1468-53) > 5 g in 1 TUBE 1 tube 2003-08-27 0000-00-00 No No Current 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