PRIMAXIN

Product NDC
0006-3516
11-digit product format
000063516
Labeler code
0006
Product ID
0006-3516_356d9feb-1498-4df7-80ad-5a935b238da6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
imipenem and cilastatin sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Merck Sharp & Dohme LLC
Application
NDA050587
Marketing category
NDA
Marketing start
1985-11-26
Substance
IMIPENEM; CILASTATIN SODIUM
Active strength
500; 500 mg/100mL; mg/100mL
Pharmacologic classes
Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]
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 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050587-001PRIMAXINCILASTATIN SODIUM; IMIPENEMEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-26
N050587-002PRIMAXINCILASTATIN SODIUM; IMIPENEMEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N050587-002AP

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-26c2088c7a36db…
2026-10-15 13:18:302026-09N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-26c2088c7a36db…
2026-09-14 22:38:342026-08N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-2684e616aacf4f…
2026-09-14 22:38:342026-08N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-2684e616aacf4f…
2026-08-18 06:07:402026-07N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAVENOUSRLD1985-11-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALPOWDER / INTRAVENOUSRLD1985-11-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050587-001PRIMAXINEQ 250MG BASE/VIAL;250MG/VIALPOWDER / INTRAVENOUSRLD1985-11-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050587-002PRIMAXINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUSAPRLD, RS1985-11-264b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N050587-002AP1c2088c7a36db…
2026-09-14 22:38:342026-08N050587-002AP184e616aacf4f…
2026-08-18 06:07:402026-07N050587-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050587-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050587-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050587-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050587-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050587-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050587-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050587-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050587-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050587-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050587-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050587-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050587-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050587-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050587-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050587-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050587-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050587-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050587-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050587-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050587-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050587-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N050587-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050587-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050587-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050587-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N050587-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050587-002AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050587-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050587-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050587-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050587-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050587-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050587-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050587-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N050587-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N050587-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050587-002AP13a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
PRIMAXIN
Brand name suffix
IV
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMIPENEM500 mg/100mL
CILASTATIN SODIUM500 mg/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bd5bade3-1b69-46d8-87bd-7d2fbe32b767Product name120200603
bc64ce14-a963-4b05-9b71-737977847052Product name120191008

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-09-01These highlights do not include all the information needed to use PRIMAXIN safely and effectively. See full prescribing information for PRIMAXIN. PRIMAXIN® (imipenem and cilastatin) for Injection, for intravenous use Initial U.S. Approval: 1985
2021-09-01These highlights do not include all the information needed to use PRIMAXIN safely and effectively. See full prescribing information for PRIMAXIN. PRIMAXIN® (imipenem and cilastatin) for Injection, for intravenous use Initial U.S. Approval: 1985
2021-09-01These highlights do not include all the information needed to use PRIMAXIN safely and effectively. See full prescribing information for PRIMAXIN. PRIMAXIN® (imipenem and cilastatin) for Injection, for intravenous use Initial U.S. Approval: 1985
2021-07-23These highlights do not include all the information needed to use PRIMAXIN safely and effectively. See full prescribing information for PRIMAXIN. PRIMAXIN® (imipenem and cilastatin) for Injection, for intravenous use Initial U.S. Approval: 1985
2021-07-23These highlights do not include all the information needed to use PRIMAXIN safely and effectively. See full prescribing information for PRIMAXIN. PRIMAXIN® (imipenem and cilastatin) for Injection, for intravenous use Initial U.S. Approval: 1985
2021-07-23These highlights do not include all the information needed to use PRIMAXIN safely and effectively. See full prescribing information for PRIMAXIN. PRIMAXIN® (imipenem and cilastatin) for Injection, for intravenous use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-3516-59PRIMAXINIV25 in 1 TRAYINJECTION, POWDER, FOR SOLUTION2534
0006-3516-59PRIMAXINIV100 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION10034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-3516-59EA - Each0006-3516bf067233-fe2b-40e1-87b0-3b467007db7512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-3516PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME LLC]33Current NDC, Legacy NDC, 2 package rows20240713_f41d8abd-7792-4918-1b93-bd83ea01955e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726204imipenem / cilastatin 250 MG InjectionPSNf41d8abd-7792-4918-1b93-bd83ea01955e34
1726214imipenem / cilastatin 500 MG InjectionPSNf41d8abd-7792-4918-1b93-bd83ea01955e34
1726207Primaxin 250 MG InjectionPSNf41d8abd-7792-4918-1b93-bd83ea01955e34
1726216Primaxin 500 MG InjectionPSNf41d8abd-7792-4918-1b93-bd83ea01955e34
1726207cilastatin 250 MG / imipenem 250 MG Injection [Primaxin]SBDf41d8abd-7792-4918-1b93-bd83ea01955e34
1726216cilastatin 500 MG / imipenem 500 MG Injection [Primaxin]SBDf41d8abd-7792-4918-1b93-bd83ea01955e34
1726204cilastatin 250 MG / imipenem 250 MG InjectionSCDf41d8abd-7792-4918-1b93-bd83ea01955e34
1726214cilastatin 500 MG / imipenem 500 MG InjectionSCDf41d8abd-7792-4918-1b93-bd83ea01955e34
1726204cilastatin (as cilastatin sodium) 250 MG / imipenem 250 MG InjectionSYf41d8abd-7792-4918-1b93-bd83ea01955e34
1726214cilastatin (as cilastatin sodium) 500 MG / imipenem 500 MG InjectionSYf41d8abd-7792-4918-1b93-bd83ea01955e34
1726204imipenem 250 MG / cilastatin 250 MG InjectionSYf41d8abd-7792-4918-1b93-bd83ea01955e34
1726214imipenem 500 MG / cilastatin 500 MG InjectionSYf41d8abd-7792-4918-1b93-bd83ea01955e34
1726207Primaxin 250 MG InjectionSYf41d8abd-7792-4918-1b93-bd83ea01955e34
1726216Primaxin 500 MG InjectionSYf41d8abd-7792-4918-1b93-bd83ea01955e34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0006-3516-590000635165925 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) / 100 mL in 1 VIAL, SINGLE-DOSE1985-11-260000-00-00NoNoCurrent