Home NDC 68788-8150-3 Lidocaine and Prilocaine
Product NDC 68788-8150
Requested package NDC 68788-8150-3
11-digit product format 687888150
Labeler code 68788
Product ID 68788-8150_b191829c-defb-4632-966e-134dda8ec959
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lidocaine and prilocaine
Dosage form CREAM
Route TOPICAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA076453
Marketing category ANDA
Marketing start 2003-08-18
Substance LIDOCAINE; PRILOCAINE
Active strength 25; 25 mg/g; mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], 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 A076453-001 LIDOCAINE AND PRILOCAINE LIDOCAINE; PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076453-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076453-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-08-18 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 and Prilocaine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 25 mg/g PRILOCAINE 25 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup 046O35D44R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197877 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-8150-3 Lidocaine and Prilocaine 30 g in 1 TUBE CREAM 30 4 68788-8150-3 Lidocaine and Prilocaine 1 in 1 CARTON CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8150 LIDOCAINE AND PRILOCAINE CREAM [PREFERRED PHARMACEUTICALS INC.] 2 Current NDC, 2 package rows 20240621_69fed044-a6b8-40a7-9ba1-7fb10435ca74.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8150-3 68788815003 1 TUBE in 1 CARTON (68788-8150-3) / 30 g in 1 TUBE 1 tube 2022-03-04 No No Current