Home NDC 0641-6054 MEPERIDINE HYDROCHLORIDE
Product NDC 0641-6054
11-digit product format 006416054
Labeler code 0641
Product ID 0641-6054_9566d54d-7343-4695-94ff-8b5f2d384c81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MEPERIDINE HYDROCHLORIDE
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA080445
Marketing category ANDA
Marketing start 1975-01-22
Substance MEPERIDINE HYDROCHLORIDE
Active strength 100 mg/mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2026-12-31
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080445-001 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP Approved before 1982 A080445-002 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP Approved before 1982 A080445-003 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE / INJECTION AP Approved before 1982 A080445-004 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 168 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 A080445-001 MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A080445-002 MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A080445-003 MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A080445-004 MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A080445-001 MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A080445-002 MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A080445-003 MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A080445-004 MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080445-001 MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080445-002 MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080445-003 MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080445-004 MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080445-001 MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A080445-002 MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A080445-003 MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A080445-004 MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080445-001 MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080445-002 MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080445-003 MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080445-004 MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080445-001 MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080445-002 MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080445-003 MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080445-004 MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080445-001 MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080445-002 MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080445-003 MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE / INJECTION AP Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080445-004 MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080445-001 MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080445-002 MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080445-003 MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE / INJECTION AP Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080445-004 MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080445-001 MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080445-002 MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080445-003 MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE / INJECTION AP Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080445-004 MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080445-001 MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080445-002 MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080445-003 MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE / INJECTION AP Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080445-004 MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP Approved before 1982 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base MEPERIDINE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEPERIDINE HYDROCHLORIDE 100 mg/mL
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 861476 Internal RxNorm lookup 1665685 Internal RxNorm lookup 1665697 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 0641-6054-01 MEPERIDINE HYDROCHLORIDE 1 mL in 1 VIAL INJECTION 1 11 0641-6054-25 MEPERIDINE HYDROCHLORIDE 25 in 1 CARTON INJECTION 25 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6054 MEPERIDINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 11 Current NDC, Legacy NDC, 2 package rows 20240410_e0e998da-f056-4fce-be8e-ed60cf3b461b.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 0641-6054-01 00641605401 1 mL in 1 VIAL 1 ml Historical 0641-6054-25 00641605425 25 VIAL in 1 CARTON (0641-6054-25) / 1 mL in 1 VIAL (0641-6054-01) 25 vial 1975-01-22 0000-00-00 No No Current