Home NDC 0054-4596 Meperidine Hydrochloride
Product NDC 0054-4596
11-digit product format 000544596
Labeler code 0054
Product ID 0054-4596_8f8568f2-250a-452e-8c1c-df934b9574f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meperidine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler West-Ward Pharmaceuticals Corp.
Application ANDA040110
Marketing category ANDA
Marketing start 1997-03-12
Marketing end 2021-08-23
Substance MEPERIDINE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0054-4596-25 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0054-4596-25 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0054-4596-25 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0054-4596-25 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0054-4596-25 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0054-4596-25 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0054-4596-25 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0054-4596-25 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0054-4596-25 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0054-4596-25 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0054-4596-25 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0054-4596-25 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040110-001 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 A040110-002 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12
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 3 · 84 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 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1997-03-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL AA RS 1997-03-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040110-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-03-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040110-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-03-12 bb7c543d1eb4…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-4596-25 Meperidine Hydrochloride 100 in 1 BOTTLE TABLET 100 25 0054-4596-25 Meperidine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET 100 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 0054-4596 MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 20 Legacy NDC, 1 package rows 20240727_15bc51a8-1e24-4d33-9a2f-05a41c29acf0.zip 0054-4596 MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM] 1 Legacy NDC 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 0054-4596-25 00054459625 100 TABLET in 1 BOTTLE (0054-4596-25) 100 tablet 1997-03-12 2021-08-23 No No Current