Home NDC 0054-3545 Meperidine Hydrochloride
Product NDC 0054-3545
11-digit product format 000543545
Labeler code 0054
Product ID 0054-3545_677fb454-d83d-4c3c-b095-a58a1c4781b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meperidine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA088744
Marketing category ANDA
Marketing start 1985-01-30
Substance MEPERIDINE HYDROCHLORIDE
Active strength 50 mg/5mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
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 42 .
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 A088744-001 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30
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 · 42 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 2026-08-18 06:07:40 2026-07 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088744-001 MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP / ORAL RS 1985-01-30 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Meperidine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEPERIDINE HYDROCHLORIDE 50 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N8E7F7Q170 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861455 Internal RxNorm lookup 861467 Internal RxNorm lookup 861479 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 0054-3545-63 Meperidine Hydrochloride 500 mL in 1 BOTTLE SOLUTION 500 25 0054-3545-63 Meperidine Hydrochloride 500 mL in 1 BOTTLE, PLASTIC SOLUTION 500 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEPERIDINE HYDROCHLORIDE ACTIVE INGREDIENT N8E7F7Q170 MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 MEPERIDINE ACTIVE MOIETY 9E338QE28F MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 MALTOL INACTIVE INGREDIENT 3A9RD92BS4 MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 POVIDONE INACTIVE INGREDIENT FZ989GH94E MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] 4 meperidine hydrochloride ACTIVE INGREDIENT N8E7F7Q170 MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 meperidine ACTIVE MOIETY 9E338QE28F MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 croscarmellose sodium INACTIVE INGREDIENT MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 hydrochloric acid INACTIVE INGREDIENT QTT17582CB MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 lactose monohydrate INACTIVE INGREDIENT MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 maltol INACTIVE INGREDIENT MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 micro-crystalline cellulose INACTIVE INGREDIENT MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 povidone INACTIVE INGREDIENT MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 pregelatinized starch INACTIVE INGREDIENT MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 sorbitol solution INACTIVE INGREDIENT MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 starch (corn) INACTIVE INGREDIENT MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 water INACTIVE INGREDIENT MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-3545 MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 20 Current NDC, Legacy NDC, 1 package rows 20240727_15bc51a8-1e24-4d33-9a2f-05a41c29acf0.zip 0054-3545 MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 Current NDC, Legacy NDC, 1 package rows 20060621_9C4F12E5-5E69-44D4-81A5-BD72C375EEF5.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 0054-3545-63 00054354563 500 mL in 1 BOTTLE (0054-3545-63) 500 ml 1985-01-30 0000-00-00 No No Current