Cefotan

Product NDC: 0121-0976
11-digit product format: 001210976
Labeler code: 0121
Product ID: 0121-0976_7e29cb53-c401-49b0-9b47-209601f7ec55
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefotetan
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: NDA050588
Marketing category: NDA
Marketing start: 2024-04-08
Substance: CEFOTETAN DISODIUM
Active strength: 1 g/10mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050588-001	CEFOTAN	CEFOTETAN DISODIUM	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27
N050588-002	CEFOTAN	CEFOTETAN DISODIUM	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27
N050588-003	CEFOTAN	CEFOTETAN DISODIUM	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N050588-001	AP
N050588-002	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1988-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050588-002	CEFOTAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050588-003	CEFOTAN	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			1988-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050588-001	CEFOTAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1985-12-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050588-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050588-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050588-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050588-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050588-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050588-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050588-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050588-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050588-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050588-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050588-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050588-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050588-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050588-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050588-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050588-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050588-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050588-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050588-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050588-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050588-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050588-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050588-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050588-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050588-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050588-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050588-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050588-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050588-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050588-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050588-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050588-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050588-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050588-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050588-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050588-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050588-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050588-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050588-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050588-002	AP	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cefotan
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFOTETAN DISODIUM	1 g/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0GXP746VXB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1722919	Internal RxNorm lookup
1722921	Internal RxNorm lookup
1731542	Internal RxNorm lookup
1743557	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
f1510f5e-d001-44e0-accb-27cf79fd4f9a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0cc1eec0-2b75-6316-520b-142bcbbb9bb7	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0121-0976-10	Cefotan	10 in 1 TRAY	INJECTION, POWDER, FOR SOLUTION	10		6
0121-0976-55	Cefotan	10 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0976-10	EA - Each	0121-0976	8d9c3244-8e0d-4674-af43-10a9947422db	1	2024-05-16
0121-0976-55	EA - Each	0121-0976	ee8f929f-11f1-41ea-a482-7fc965c3aee6	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0976	CEFOTAN (CEFOTETAN) INJECTION, POWDER, FOR SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	6	Current NDC, 2 package rows	20240410_f1510f5e-d001-44e0-accb-27cf79fd4f9a.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
Cefotan	CEFOTETAN	PAI Holdings, LLC dba PAI Pharma	f1510f5e-d001-44e0-accb-27cf79fd4f9a	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050588 application number: NDA050588 ndc (product): 0121-0976

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0GXP746VXB	CEFOTETAN DISODIUM	74356-00-6	CEFOTETAN DISODIUM
48SPP0PA9Q	CEFOTETAN	69712-56-7	Cefotetan

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1731542	Cefotan 1 GM Injection	PSN	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6
1743557	Cefotan 2 GM Injection	PSN	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6
1722919	cefoTEtan 1 GM Injection	PSN	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6
1722921	cefoTEtan 2 GM Injection	PSN	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6
1731542	cefotetan 1000 MG Injection [Cefotan]	SBD	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6
1743557	cefotetan 2000 MG Injection [Cefotan]	SBD	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6
1722919	cefotetan 1000 MG Injection	SCD	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6
1722921	cefotetan 2000 MG Injection	SCD	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6
1731542	Cefotan 1 GM Injection	SY	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6
1731542	Cefotan 1000 MG Injection	SY	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6
1743557	Cefotan 2 GM Injection	SY	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6
1722919	cefotetan (as disodium) 1 GM Injection	SY	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6
1722921	cefotetan (as disodium) 2 GM Injection	SY	f1510f5e-d001-44e0-accb-27cf79fd4f9a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0121-0976-10	00121097610	10 VIAL in 1 TRAY (0121-0976-10) / 10 mL in 1 VIAL (0121-0976-55)	10 vial	2024-04-08	No	No	Current
0121-0976-55	00121097655	10 mL in 1 VIAL	10 ml				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEFOTAN ® (Cefotetan for Injection, USP)	PAI Holdings, LLC dba PAI Pharma	2024-04-08	HUMAN PRESCRIPTION DRUG LABEL	6