PRIMAXIN

Product NDC: 0006-3516
11-digit product format: 000063516
Labeler code: 0006
Product ID: 0006-3516_34854f9b-7be0-4bfb-8cd2-40baf206fb80
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: CILASTATIN SODIUM; IMIPENEM
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: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
CILASTATIN SODIUM	500 mg/100mL
IMIPENEM	500 mg/100mL

Field, Values table
Field	Values
Unii	5428WXZ74M, 71OTZ9ZE0A
Rxcui	1726204, 1726207, 1726214, 1726216

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bd5bade3-1b69-46d8-87bd-7d2fbe32b767	Product name	1	20200603
bc64ce14-a963-4b05-9b71-737977847052	Product name	1	20191008

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0006-3516-59	2021-09-01	C162847	48780-1	c7ccaba7-2ae7-fd44-e053-dadaa90aa01b	These 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
0006-3516-59	2021-09-01	C162847	48780-1	c7ccaba7-2ae7-fd44-e053-dadaa90aa01b	These 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
0006-3516-59	2021-07-23	C162847	48780-1	c7ccaba7-2ae7-fd44-e053-dadaa90aa01b	These 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
0006-3516-59	2021-07-23	C162847	48780-1	c7ccaba7-2ae7-fd44-e053-dadaa90aa01b	These 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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0006-3516-59	PRIMAXINIV	25 in 1 TRAY	INJECTION, POWDER, FOR SOLUTION	25		34
0006-3516-59	PRIMAXINIV	100 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, FOR SOLUTION	100		34

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-3516-59	EA - Each	0006-3516	bf067233-fe2b-40e1-87b0-3b467007db75	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CILASTATIN SODIUM	ACTIVE INGREDIENT	5428WXZ74M	PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	16
IMIPENEM	ACTIVE INGREDIENT	71OTZ9ZE0A	PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	16
CILASTATIN	ACTIVE MOIETY	141A6AMN38	PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	16
IMIPENEM ANHYDROUS	ACTIVE MOIETY	Q20IM7HE75	PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	16
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	16

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0006-3516	PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME LLC]	33	Current NDC, Legacy NDC, 2 package rows	20240713_f41d8abd-7792-4918-1b93-bd83ea01955e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5428WXZ74M	CILASTATIN SODIUM	81129-83-1	CILASTATIN SODIUM
71OTZ9ZE0A	IMIPENEM	74431-23-5	IMIPENEM

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1726204	imipenem / cilastatin 250 MG Injection	PSN	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726214	imipenem / cilastatin 500 MG Injection	PSN	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726207	Primaxin 250 MG Injection	PSN	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726216	Primaxin 500 MG Injection	PSN	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726207	cilastatin 250 MG / imipenem 250 MG Injection [Primaxin]	SBD	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726216	cilastatin 500 MG / imipenem 500 MG Injection [Primaxin]	SBD	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726204	cilastatin 250 MG / imipenem 250 MG Injection	SCD	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726214	cilastatin 500 MG / imipenem 500 MG Injection	SCD	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726204	cilastatin (as cilastatin sodium) 250 MG / imipenem 250 MG Injection	SY	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726214	cilastatin (as cilastatin sodium) 500 MG / imipenem 500 MG Injection	SY	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726204	imipenem 250 MG / cilastatin 250 MG Injection	SY	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726214	imipenem 500 MG / cilastatin 500 MG Injection	SY	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726207	Primaxin 250 MG Injection	SY	f41d8abd-7792-4918-1b93-bd83ea01955e	34
1726216	Primaxin 500 MG Injection	SY	f41d8abd-7792-4918-1b93-bd83ea01955e	34

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0006-3516-59	00006351659	25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) / 100 mL in 1 VIAL, SINGLE-DOSE	1985-11-26	0000-00-00	No	No	Current