Home NDC 42806-051 Meperidine Hydrochloride
Product NDC 42806-051
11-digit product format 428060051
Labeler code 42806
Product ID 42806-051_a2109eab-1e10-4549-adee-0700efae6f3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meperidine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler EPIC PHARMA, LLC
Application ANDA040331
Marketing category ANDA
Marketing start 2011-05-05
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 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040331-001 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 A040331-002 MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040331-001 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 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 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 1999-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1999-05-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1999-05-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1999-05-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL AA 1999-05-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1999-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040331-001 MEPERIDINE HYDROCHLORIDE 50MG TABLET / ORAL 1999-05-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040331-002 MEPERIDINE HYDROCHLORIDE 100MG TABLET / ORAL 1999-05-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# 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/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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861455 Internal RxNorm lookup 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 42806-051-01 Meperidine Hydrochloride 100 in 1 BOTTLE TABLET 100 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEPERIDINE HYDROCHLORIDE ACTIVE INGREDIENT N8E7F7Q170 MEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 8 MEPERIDINE ACTIVE MOIETY 9E338QE28F MEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 8 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-051 MEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 27 Current NDC, Legacy NDC, 1 package rows 20241222_fae5cc34-5917-4445-9516-25f97ffca8db.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 42806-051-01 42806005101 100 TABLET in 1 BOTTLE (42806-051-01) 100 tablet 2011-05-05 0000-00-00 No No Current