CEFOTAN

Product NDC: 52565-053
11-digit product format: 525650053
Labeler code: 52565
Product ID: 52565-053_675e1e86-13c2-4287-b4ed-cc60d01b9acc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cefotetan disodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Teligent Pharma, Inc.
Application: NDA050588
Marketing category: NDA
Marketing start: 2015-10-01
Marketing end: 0000-00-00
Substance: CEFOTETAN DISODIUM
Active strength: 2 g/20mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52565-053		I	Inactivated by FDA		2026-08-03
excluded package	package	52565-053	52565-053-10	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 22 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	52565-053		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52565-053	52565-053-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	52565-053		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52565-053	52565-053-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	52565-053		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52565-053	52565-053-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	52565-053		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52565-053	52565-053-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	52565-053		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52565-053	52565-053-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	52565-053		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52565-053	52565-053-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	52565-053		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52565-053	52565-053-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	52565-053		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52565-053	52565-053-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	52565-053		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52565-053	52565-053-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	52565-053		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52565-053	52565-053-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	52565-053		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52565-053	52565-053-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`

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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52565-053-10	2022-01-28	C162847	48780-1	d6a99b39-d1a9-a426-e053-dadaa90af4c2	CEFOTAN ® (Cefotetan for injection, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52565-053-10	CEFOTAN	20 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	20		5
52565-053-10	CEFOTAN	10 in 1 TRAY	INJECTION, POWDER, FOR SOLUTION	10		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-053-10	EA - Each	52565-053	23e0a3b6-08b7-4fb9-92d2-44be780ccc59	1	2016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-053	CEFOTAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION CEFOTAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION [TELIGENT PHARMA, INC.]	5	Legacy NDC, 2 package rows	20190207_0860bfe0-da3e-4460-da57-2411db14c426.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0GXP746VXB	CEFOTETAN DISODIUM	74356-00-6	CEFOTETAN DISODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1731542	Cefotan 1 GM Injection	PSN	0860bfe0-da3e-4460-da57-2411db14c426	5
1743557	Cefotan 2 GM Injection	PSN	0860bfe0-da3e-4460-da57-2411db14c426	5
1722919	cefoTEtan 1 GM Injection	PSN	0860bfe0-da3e-4460-da57-2411db14c426	5
1722921	cefoTEtan 2 GM Injection	PSN	0860bfe0-da3e-4460-da57-2411db14c426	5
1731542	cefotetan 1000 MG Injection [Cefotan]	SBD	0860bfe0-da3e-4460-da57-2411db14c426	5
1743557	cefotetan 2000 MG Injection [Cefotan]	SBD	0860bfe0-da3e-4460-da57-2411db14c426	5
1722919	cefotetan 1000 MG Injection	SCD	0860bfe0-da3e-4460-da57-2411db14c426	5
1722921	cefotetan 2000 MG Injection	SCD	0860bfe0-da3e-4460-da57-2411db14c426	5
1731542	Cefotan 1 GM Injection	SY	0860bfe0-da3e-4460-da57-2411db14c426	5
1731542	Cefotan 1000 MG Injection	SY	0860bfe0-da3e-4460-da57-2411db14c426	5
1743557	Cefotan 2 GM Injection	SY	0860bfe0-da3e-4460-da57-2411db14c426	5
1722919	cefotetan (as disodium) 1 GM Injection	SY	0860bfe0-da3e-4460-da57-2411db14c426	5
1722921	cefotetan (as disodium) 2 GM Injection	SY	0860bfe0-da3e-4460-da57-2411db14c426	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-053-10	52565005310	10 VIAL in 1 TRAY (52565-053-10) > 20 mL in 1 VIAL	10 vial	2015-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEFOTAN ® (Cefotetan for injection, USP)	Teligent Pharma, Inc. \| ACSDobfar S.p.A	2018-11-30	HUMAN PRESCRIPTION DRUG LABEL	5