meperidine hydrochloride

Product NDC
46672-829
11-digit product format
466720829
Labeler code
46672
Product ID
46672-829_9c56afa2-bfa0-fa03-e053-2995a90a7437
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meperidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mikart, LLC
Application
ANDA040893
Marketing category
ANDA
Marketing start
2009-06-24
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040893-001MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDE50MGTABLET / ORALAA2009-06-24
A040893-002MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDE75MGTABLET / ORAL2009-06-24
A040893-003MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2009-06-24
A040893-004MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDE150MGTABLET / ORAL2009-06-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040893-001AA

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040893-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORALAA2009-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040893-002MEPERIDINE HYDROCHLORIDE75MGTABLET / ORAL2009-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040893-003MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2009-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040893-004MEPERIDINE HYDROCHLORIDE150MGTABLET / ORAL2009-06-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040893-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORALAA2009-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040893-002MEPERIDINE HYDROCHLORIDE75MGTABLET / ORAL2009-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040893-003MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2009-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040893-004MEPERIDINE HYDROCHLORIDE150MGTABLET / ORAL2009-06-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040893-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORALAA2009-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040893-002MEPERIDINE HYDROCHLORIDE75MGTABLET / ORAL2009-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040893-003MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2009-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040893-004MEPERIDINE HYDROCHLORIDE150MGTABLET / ORAL2009-06-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040893-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORALAA2009-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040893-002MEPERIDINE HYDROCHLORIDE75MGTABLET / ORAL2009-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040893-003MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2009-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040893-004MEPERIDINE HYDROCHLORIDE150MGTABLET / ORAL2009-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040893-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORALAA2009-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040893-002MEPERIDINE HYDROCHLORIDE75MGTABLET / ORAL2009-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040893-003MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2009-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040893-004MEPERIDINE HYDROCHLORIDE150MGTABLET / ORAL2009-06-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040893-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORALAA2009-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040893-002MEPERIDINE HYDROCHLORIDE75MGTABLET / ORAL2009-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040893-003MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2009-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040893-004MEPERIDINE HYDROCHLORIDE150MGTABLET / ORAL2009-06-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040893-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORALAA2009-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040893-002MEPERIDINE HYDROCHLORIDE75MGTABLET / ORAL2009-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040893-003MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2009-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040893-004MEPERIDINE HYDROCHLORIDE150MGTABLET / ORAL2009-06-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040893-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORALAA2009-06-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040893-002MEPERIDINE HYDROCHLORIDE75MGTABLET / ORAL2009-06-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040893-003MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2009-06-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040893-004MEPERIDINE HYDROCHLORIDE150MGTABLET / ORAL2009-06-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040893-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORALAA2009-06-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040893-002MEPERIDINE HYDROCHLORIDE75MGTABLET / ORAL2009-06-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040893-003MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2009-06-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040893-004MEPERIDINE HYDROCHLORIDE150MGTABLET / ORAL2009-06-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040893-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORALAA2009-06-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A040893-002MEPERIDINE HYDROCHLORIDE75MGTABLET / ORAL2009-06-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A040893-003MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2009-06-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A040893-004MEPERIDINE HYDROCHLORIDE150MGTABLET / ORAL2009-06-24d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040893-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040893-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040893-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040893-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040893-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040893-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040893-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040893-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040893-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040893-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040893-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040893-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040893-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040893-001AA18072bd15b7f6…
2019-07-19 19:46 UTC2019-07A040893-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040893-003AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040893-001AA16a51e52b5d6a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040893-001AA1a50c72e98297…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEPERIDINE HYDROCHLORIDEACTIVE INGREDIENTN8E7F7Q170MEPERIDINE HYDROCHLORIDE TABLET [MIKART, INC.]1
MEPERIDINEACTIVE MOIETY9E338QE28FMEPERIDINE HYDROCHLORIDE TABLET [MIKART, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEPERIDINE HYDROCHLORIDE TABLET [MIKART, INC.]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KMEPERIDINE HYDROCHLORIDE TABLET [MIKART, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEPERIDINE HYDROCHLORIDE TABLET [MIKART, INC.]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4MEPERIDINE HYDROCHLORIDE TABLET [MIKART, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEPERIDINE HYDROCHLORIDE TABLET [MIKART, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MEPERIDINE HYDROCHLORIDE TABLET [MIKART, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMEPERIDINE HYDROCHLORIDE TABLET [MIKART, INC.]1

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meperidine HydrochlorideMEPERIDINE HYDROCHLORIDEGenus Lifesciences Inc.792fefda-6cc4-4709-b902-fd9787fc310a2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040893
application number: ANDA040893

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46672-829-1046672082910100 TABLET in 1 BOTTLE, PLASTIC (46672-829-10) 100 tablet2009-06-240000-00-00NoNoCurrent
46672-829-5046672082950500 TABLET in 1 BOTTLE, PLASTIC (46672-829-50) 500 tablet2009-06-240000-00-00NoNoCurrent