Home NDC 64950-214 Meperidine Hydrochloride
Product NDC 64950-214
11-digit product format 649500214
Labeler code 64950
Product ID 64950-214_0f126de5-64f4-4a0d-8caa-e97acc3a2611
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meperidine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Genus Lifesciences Inc.
Application ANDA040893
Marketing category ANDA
Marketing start 2024-02-14
Substance MEPERIDINE HYDROCHLORIDE
Active strength 50 mg/1
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040893-001 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2009-06-24 A040893-002 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 75MG TABLET / ORAL 2009-06-24 A040893-003 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 2009-06-24 A040893-004 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 150MG TABLET / ORAL 2009-06-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040893-001 AA
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 A040893-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2009-06-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040893-002 MEPERIDINE HYDROCHLORIDE 75MG TABLET / ORAL 2009-06-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040893-003 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 2009-06-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040893-004 MEPERIDINE HYDROCHLORIDE 150MG TABLET / ORAL 2009-06-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040893-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2009-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040893-002 MEPERIDINE HYDROCHLORIDE 75MG TABLET / ORAL 2009-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040893-003 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 2009-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040893-004 MEPERIDINE HYDROCHLORIDE 150MG TABLET / ORAL 2009-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040893-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2009-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040893-002 MEPERIDINE HYDROCHLORIDE 75MG TABLET / ORAL 2009-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040893-003 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 2009-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040893-004 MEPERIDINE HYDROCHLORIDE 150MG TABLET / ORAL 2009-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040893-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2009-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040893-002 MEPERIDINE HYDROCHLORIDE 75MG TABLET / ORAL 2009-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040893-003 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 2009-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040893-004 MEPERIDINE HYDROCHLORIDE 150MG TABLET / ORAL 2009-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040893-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2009-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040893-002 MEPERIDINE HYDROCHLORIDE 75MG TABLET / ORAL 2009-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040893-003 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 2009-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040893-004 MEPERIDINE HYDROCHLORIDE 150MG TABLET / ORAL 2009-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040893-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2009-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040893-002 MEPERIDINE HYDROCHLORIDE 75MG TABLET / ORAL 2009-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040893-003 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 2009-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040893-004 MEPERIDINE HYDROCHLORIDE 150MG TABLET / ORAL 2009-06-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040893-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2009-06-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040893-002 MEPERIDINE HYDROCHLORIDE 75MG TABLET / ORAL 2009-06-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040893-003 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 2009-06-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040893-004 MEPERIDINE HYDROCHLORIDE 150MG TABLET / ORAL 2009-06-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040893-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2009-06-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040893-002 MEPERIDINE HYDROCHLORIDE 75MG TABLET / ORAL 2009-06-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040893-003 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 2009-06-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040893-004 MEPERIDINE HYDROCHLORIDE 150MG TABLET / ORAL 2009-06-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040893-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2009-06-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040893-002 MEPERIDINE HYDROCHLORIDE 75MG TABLET / ORAL 2009-06-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040893-003 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 2009-06-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040893-004 MEPERIDINE HYDROCHLORIDE 150MG TABLET / ORAL 2009-06-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040893-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2009-06-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040893-002 MEPERIDINE HYDROCHLORIDE 75MG TABLET / ORAL 2009-06-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040893-003 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 2009-06-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040893-004 MEPERIDINE HYDROCHLORIDE 150MG TABLET / ORAL 2009-06-24 d8e5a09893c0…
Observed Orange Book normalized TE history# 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/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861467 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 64950-214-01 Meperidine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET 100 2 64950-214-03 Meperidine Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64950-214 MEPERIDINE HYDROCHLORIDE TABLET [GENUS LIFESCIENCES INC.] 1 Current NDC, 2 package rows 20240222_792fefda-6cc4-4709-b902-fd9787fc310a.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 Sample Exclude flag Status 64950-214-01 64950021401 100 TABLET in 1 BOTTLE, PLASTIC (64950-214-01) 100 tablet 2024-02-14 No No Current 64950-214-03 64950021403 30 TABLET in 1 BOTTLE, PLASTIC (64950-214-03) 30 tablet 2024-02-14 No No Current