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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050587-001	PRIMAXIN	CILASTATIN SODIUM; IMIPENEM	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26
N050587-002	PRIMAXIN	CILASTATIN SODIUM; IMIPENEM	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26

Therapeutic equivalence codes#

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

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

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		RLD	1985-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		RLD	1985-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL	POWDER / INTRAVENOUS		RLD	1985-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050587-001	PRIMAXIN	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	1985-11-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050587-002	PRIMAXIN	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	1985-11-26	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N050587-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050587-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050587-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050587-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050587-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050587-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050587-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050587-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050587-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050587-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050587-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050587-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050587-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050587-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050587-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050587-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050587-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050587-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050587-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050587-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050587-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050587-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050587-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050587-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050587-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050587-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050587-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050587-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050587-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050587-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050587-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050587-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050587-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050587-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050587-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050587-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050587-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050587-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050587-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050587-002	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: PRIMAXIN
Brand name suffix: IV
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
71OTZ9ZE0A	Internal UNII lookup
5428WXZ74M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1726204	Internal RxNorm lookup
1726207	Internal RxNorm lookup
1726214	Internal RxNorm lookup
1726216	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f41d8abd-7792-4918-1b93-bd83ea01955e	Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2021-09-01	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
2021-09-01	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
2021-07-23	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
2021-07-23	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

DailyMed Package Descriptions#

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

DailyMed Billing Units#

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

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

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

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRIMAXIN IV	IMIPENEM AND CILASTATIN SODIUM	Merck Sharp & Dohme LLC	f41d8abd-7792-4918-1b93-bd83ea01955e	2024-07-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050587 application number: NDA050587 ndc (product): 0006-3516

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

DailyMed RxNorm Mappings#

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

Packages#

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