DEMEROL

Product NDC
0409-1253
11-digit product format
004091253
Labeler code
0409
Product ID
0409-1253_8df6e324-9a3c-4f21-a08c-620cd45c551a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEPERIDINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hospira, Inc.
Application
NDA021171
Marketing category
NDA
Marketing start
2006-01-04
Marketing end
2020-10-01
Substance
MEPERIDINE HYDROCHLORIDE
Active strength
50 mg/mL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-1253DDiscontinued by firm2026-08-17
excluded packagepackage0409-12530409-1253-01DDiscontinued by firm2026-08-17

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-1253-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-1253-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-1253-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-1253-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-1253-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-1253-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-1253-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-1253-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-1253-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-1253-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-1253-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-1253-01557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021171-001DEMEROLMEPERIDINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N021171-002DEMEROLMEPERIDINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N021171-003DEMEROLMEPERIDINE HYDROCHLORIDE75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N021171-004DEMEROLMEPERIDINE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N021171-001AP
N021171-002AP
N021171-003AP
N021171-004AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021171-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N021171-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N021171-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N021171-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021171-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021171-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021171-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021171-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021171-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021171-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021171-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021171-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021171-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021171-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021171-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021171-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021171-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021171-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021171-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021171-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021171-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021171-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021171-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021171-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021171-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021171-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021171-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021171-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021171-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021171-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021171-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021171-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021171-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021171-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021171-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021171-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021171-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021171-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021171-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021171-004AP1d8e5a09893c0…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2957211f-7067-d29a-b09d-73e9648715c8Product name120140508
c245b765-4133-e5fc-aafb-bfde7c2f8a90Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1253-01ML - Milliliter0409-1253b5bb76fe-8cd4-4c12-9ce5-441b5229fb4212012-07-24
0409-1253-11ML - Milliliter0409-1253493c545f-b647-43a1-ba93-f495972250af12017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEPERIDINE HYDROCHLORIDEACTIVE INGREDIENTN8E7F7Q170DEMEROL (MEPERIDINE HYDROCHLORIDE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]3
MEPERIDINEACTIVE MOIETY9E338QE28FDEMEROL (MEPERIDINE HYDROCHLORIDE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]3

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
DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.b31d1308-28c3-43f4-e0a6-2f3ed76b89752026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021171
application number: NDA021171

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665687Demerol 100 MG in 1 ML InjectionPSN53ddfe26-5a7e-4f39-8904-829a03538f633
861520Demerol 100 MG/ML Injectable SolutionPSN53ddfe26-5a7e-4f39-8904-829a03538f633
861529Demerol 50 MG in 1 ML CartridgePSN53ddfe26-5a7e-4f39-8904-829a03538f633
861522Demerol 50 MG/ML Injectable SolutionPSN53ddfe26-5a7e-4f39-8904-829a03538f633
1665685meperidine HCl 100 MG in 1 ML InjectionPSN53ddfe26-5a7e-4f39-8904-829a03538f633
861459meperidine HCl 100 MG/ML Injectable SolutionPSN53ddfe26-5a7e-4f39-8904-829a03538f633
861473meperidine HCl 50 MG in 1 ML CartridgePSN53ddfe26-5a7e-4f39-8904-829a03538f633
861463meperidine HCl 50 MG/ML Injectable SolutionPSN53ddfe26-5a7e-4f39-8904-829a03538f633
16656871 ML meperidine hydrochloride 100 MG/ML Injection [Demerol]SBD53ddfe26-5a7e-4f39-8904-829a03538f633
8615291 ML meperidine hydrochloride 50 MG/ML Cartridge [Demerol]SBD53ddfe26-5a7e-4f39-8904-829a03538f633
861520meperidine hydrochloride 100 MG/ML Injectable Solution [Demerol]SBD53ddfe26-5a7e-4f39-8904-829a03538f633
861522meperidine hydrochloride 50 MG/ML Injectable Solution [Demerol]SBD53ddfe26-5a7e-4f39-8904-829a03538f633
16656851 ML meperidine hydrochloride 100 MG/ML InjectionSCD53ddfe26-5a7e-4f39-8904-829a03538f633
8614731 ML meperidine hydrochloride 50 MG/ML CartridgeSCD53ddfe26-5a7e-4f39-8904-829a03538f633
861459meperidine hydrochloride 100 MG/ML Injectable SolutionSCD53ddfe26-5a7e-4f39-8904-829a03538f633
861463meperidine hydrochloride 50 MG/ML Injectable SolutionSCD53ddfe26-5a7e-4f39-8904-829a03538f633
16656871 ML Demerol 100 MG/ML InjectionSY53ddfe26-5a7e-4f39-8904-829a03538f633
8615291 ML Demerol 50 MG/ML CartridgeSY53ddfe26-5a7e-4f39-8904-829a03538f633
1665687Demerol 100 MG per 1 ML InjectionSY53ddfe26-5a7e-4f39-8904-829a03538f633
861520Demerol 100 MG/ML Injectable SolutionSY53ddfe26-5a7e-4f39-8904-829a03538f633
861529Demerol 50 MG per 1 ML CartridgeSY53ddfe26-5a7e-4f39-8904-829a03538f633
861522Demerol 50 MG/ML Injectable SolutionSY53ddfe26-5a7e-4f39-8904-829a03538f633
1665685meperidine HCl 100 MG per 1 ML InjectionSY53ddfe26-5a7e-4f39-8904-829a03538f633
861473meperidine HCl 50 MG per 1 ML CartridgeSY53ddfe26-5a7e-4f39-8904-829a03538f633