FDA.reportPublic FDA data

Application 021171

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEMEROLMEPERIDINE HYDROCHLORIDEINJECTABLE;INJECTION25MG/MLYesYes
002DEMEROLMEPERIDINE HYDROCHLORIDEINJECTABLE;INJECTION50MG/MLYesYes
003DEMEROLMEPERIDINE HYDROCHLORIDEINJECTABLE;INJECTION75MG/MLYesYes
004DEMEROLMEPERIDINE HYDROCHLORIDEINJECTABLE;INJECTION100MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N021171-001DEMEROL25MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N021171-002DEMEROL50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N021171-003DEMEROL75MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N021171-004DEMEROL100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea99ee380514…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N021171-001AP1c2088c7a36db…
2026-10-15 13:18:302026-09N021171-002AP1c2088c7a36db…
2026-10-15 13:18:302026-09N021171-003AP1c2088c7a36db…
2026-10-15 13:18:302026-09N021171-004AP1c2088c7a36db…
2026-09-14 22:38:342026-08N021171-001AP184e616aacf4f…
2026-09-14 22:38:342026-08N021171-002AP184e616aacf4f…
2026-09-14 22:38:342026-08N021171-003AP184e616aacf4f…
2026-09-14 22:38:342026-08N021171-004AP184e616aacf4f…
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…

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
ndc (product): 0409-1181
ndc (product): 0409-1176
ndc (product): 0409-1179
ndc (product): 0409-1178
ndc (product): 0409-1180

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 105 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-1176DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1176DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1176DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1176DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1176DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1176DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1176DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1176DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1176DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1176DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1176DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1176DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1178DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1178DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1178DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1178DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1178DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1178DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1178DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1178DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1178DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1178DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1178DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1178DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1179DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1179DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1179DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1179DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1179DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1179DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1179DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1179DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1179DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1179DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1179DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1179DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1180DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1180DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1180DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1180DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1180DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1180DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1180DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1180DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1180DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1180DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1180DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1180DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1181DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1181DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1181DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1181DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1181DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1181DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1181DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1181DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1181DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1181DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1181DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1181DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1201DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1201DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1201DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1201DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1201DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1201DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1203DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1203DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1203DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1203DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1203DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1203DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1253DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1253DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1253DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1253DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1253DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1254DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1254DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1254DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84651SUPPL 2026-01-06
84567SUPPL 2025-12-29
80822SUPPL 2025-01-08
80821SUPPL 2025-01-08
77000SUPPL 2023-12-19
76903SUPPL 2023-12-18
72475SUPPL2022-10-26
60434SUPPL2019-10-09
60282SUPPL2019-10-07
46359SUPPL2016-12-21
46358SUPPL2016-12-21
46277SUPPL2016-12-20
46276SUPPL2016-12-20