Teflaro

Product NDC: 0456-0400
11-digit product format: 004560400
Labeler code: 0456
Product ID: 0456-0400_80f8b668-c4e3-472a-acfa-edececd8b7e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ceftaroline fosamil
Dosage form: POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Allergan, Inc.
Application: NDA200327
Marketing category: NDA
Marketing start: 2010-10-29
Substance: CEFTAROLINE FOSAMIL
Active strength: 400 mg/20mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N200327-001	TEFLARO	CEFTAROLINE FOSAMIL	400MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29
N200327-002	TEFLARO	CEFTAROLINE FOSAMIL	600MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N200327-001	AP
N200327-002	AP

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N200327-001	9629861	2030-09-21		Drug product	2017-05-17
N200327-001	8247400	2031-02-10	U-282	Drug product
N200327-002	9629861	2030-09-21		Drug product	2017-05-17
N200327-002	8247400	2031-02-10	U-282	Drug product

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 · 82 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	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS		RLD	2010-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2010-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200327-001	TEFLARO	400MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200327-002	TEFLARO	600MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-10-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200327-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200327-002	AP	1	`011fe1cb6892…`
2022-04-04 05:41 UTC	2022-04	N200327-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N200327-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N200327-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N200327-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200327-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200327-002	AP	1	`782e0a99824c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200327-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200327-002	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 236 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200327-001	9629861	2030-09-21		Drug product	2017-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200327-001	8247400	2031-02-10	U-282	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200327-002	9629861	2030-09-21		Drug product	2017-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200327-002	8247400	2031-02-10	U-282	Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200327-001	9629861	2030-09-21		Drug product	2017-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200327-001	8247400	2031-02-10	U-282	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200327-002	9629861	2030-09-21		Drug product	2017-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200327-002	8247400	2031-02-10	U-282	Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200327-001	9629861	2030-09-21		Drug product	2017-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200327-001	8247400	2031-02-10	U-282	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200327-002	9629861	2030-09-21		Drug product	2017-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200327-002	8247400	2031-02-10	U-282	Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200327-001	9629861	2030-09-21		Drug product	2017-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200327-001	8247400	2031-02-10	U-282	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200327-002	9629861	2030-09-21		Drug product	2017-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200327-002	8247400	2031-02-10	U-282	Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200327-001	9629861	2030-09-21		Drug product	2017-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200327-001	8247400	2031-02-10	U-282	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200327-002	9629861	2030-09-21		Drug product	2017-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200327-002	8247400	2031-02-10	U-282	Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200327-001	9629861	2030-09-21		Drug product	2017-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200327-001	8247400	2031-02-10	U-282	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200327-002	9629861	2030-09-21		Drug product	2017-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200327-002	8247400	2031-02-10	U-282	Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200327-001	9629861	2030-09-21		Drug product	2017-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200327-001	8247400	2031-02-10	U-282	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200327-002	9629861	2030-09-21		Drug product	2017-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200327-002	8247400	2031-02-10	U-282	Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200327-001	9629861	2030-09-21		Drug product	2017-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200327-001	8247400	2031-02-10	U-282	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200327-002	9629861	2030-09-21		Drug product	2017-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200327-002	8247400	2031-02-10	U-282	Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200327-001	9629861	2030-09-21		Drug product	2017-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200327-001	8247400	2031-02-10	U-282	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200327-002	9629861	2030-09-21		Drug product	2017-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200327-002	8247400	2031-02-10	U-282	Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200327-001	9629861	2030-09-21		Drug product	2017-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200327-001	8247400	2031-02-10	U-282	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200327-002	9629861	2030-09-21		Drug product	2017-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200327-002	8247400	2031-02-10	U-282	Drug product		`d06236e962d9…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200327-001	NPP	2022-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200327-002	NPP	2022-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200327-001	NPP	2022-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N200327-002	NPP	2022-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200327-001	NPP	2022-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N200327-002	NPP	2022-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200327-001	NPP	2019-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200327-001	NPP	2019-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200327-002	NPP	2019-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200327-002	NPP	2019-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200327-001	NPP	2022-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N200327-002	NPP	2022-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200327-001	NPP	2022-09-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200327-002	NPP	2022-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200327-001	NPP	2022-09-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200327-002	NPP	2022-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200327-001	NPP	2022-09-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N200327-002	NPP	2022-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200327-001	NPP	2022-09-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200327-002	NPP	2022-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200327-001	NPP	2022-09-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N200327-002	NPP	2022-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200327-001	NPP	2019-05-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200327-001	NPP	2019-05-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200327-002	NPP	2019-05-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200327-002	NPP	2019-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200327-001	NPP	2019-05-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200327-001	NPP	2019-05-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200327-002	NPP	2019-05-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200327-002	NPP	2019-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200327-001	NPP	2019-05-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200327-001	NPP	2019-05-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200327-002	NPP	2019-05-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200327-002	NPP	2019-05-27	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N200327-001	NPP	2022-09-13	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N200327-002	NPP	2022-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200327-001	NPP	2022-09-13	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200327-002	NPP	2022-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200327-001	NPP	2022-09-13	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N200327-002	NPP	2022-09-13	`f41ea6bd6efb…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFTAROLINE FOSAMIL	400 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7P6FQA5D21	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1040008	Internal RxNorm lookup
1040012	Internal RxNorm lookup
1040014	Internal RxNorm lookup
1040016	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
3ecde48b-75a2-4beb-9999-369f3f61bb8a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5748b1db-3b49-460c-ad6d-f428c51d042b	Product name	2	20220316
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0456-0400-01	Teflaro	20 mL in 1 VIAL, SINGLE-DOSE	POWDER, FOR SOLUTION	20		43
0456-0400-10	Teflaro	10 in 1 CARTON	POWDER, FOR SOLUTION	10		43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0456-0400-01	EA - Each	0456-0400	0fc22a77-53fe-479d-a843-4b3594ae298e	1	2012-07-24
0456-0400-10	EA - Each	0456-0400	4269549a-ecba-433f-ad50-2b2ce16c98cc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFTAROLINE FOSAMIL	ACTIVE INGREDIENT	7P6FQA5D21	TEFLARO (CEFTAROLINE FOSAMIL) POWDER, FOR SOLUTION [FOREST LABORATORIES, INC. ]	17
CEFTAROLINE	ACTIVE MOIETY	H36Z0FHR8K	TEFLARO (CEFTAROLINE FOSAMIL) POWDER, FOR SOLUTION [FOREST LABORATORIES, INC. ]	17
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	TEFLARO (CEFTAROLINE FOSAMIL) POWDER, FOR SOLUTION [FOREST LABORATORIES, INC. ]	17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0456-0400	TEFLARO (CEFTAROLINE FOSAMIL) POWDER, FOR SOLUTION [ALLERGAN, INC.]	42	Current NDC, Legacy NDC, 2 package rows	20241127_3ecde48b-75a2-4beb-9999-369f3f61bb8a.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
Teflaro	CEFTAROLINE FOSAMIL	Allergan, Inc.	3ecde48b-75a2-4beb-9999-369f3f61bb8a	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200327 application number: NDA200327 ndc (product): 0456-0400

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7P6FQA5D21	CEFTAROLINE FOSAMIL	229016-73-3	CEFTAROLINE FOSAMIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1040008	ceftaroline fosamil 400 MG Injection	PSN	3ecde48b-75a2-4beb-9999-369f3f61bb8a	43
1040014	ceftaroline fosamil 600 MG Injection	PSN	3ecde48b-75a2-4beb-9999-369f3f61bb8a	43
1040012	Teflaro 400 MG Injection	PSN	3ecde48b-75a2-4beb-9999-369f3f61bb8a	43
1040016	Teflaro 600 MG Injection	PSN	3ecde48b-75a2-4beb-9999-369f3f61bb8a	43
1040012	ceftaroline fosamil 400 MG Injection [Teflaro]	SBD	3ecde48b-75a2-4beb-9999-369f3f61bb8a	43
1040016	ceftaroline fosamil 600 MG Injection [Teflaro]	SBD	3ecde48b-75a2-4beb-9999-369f3f61bb8a	43
1040008	ceftaroline fosamil 400 MG Injection	SCD	3ecde48b-75a2-4beb-9999-369f3f61bb8a	43
1040014	ceftaroline fosamil 600 MG Injection	SCD	3ecde48b-75a2-4beb-9999-369f3f61bb8a	43
1040012	Teflaro 400 MG Injection	SY	3ecde48b-75a2-4beb-9999-369f3f61bb8a	43
1040016	Teflaro 600 MG Injection	SY	3ecde48b-75a2-4beb-9999-369f3f61bb8a	43

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0456-0400-01	00456040001	20 mL in 1 VIAL, SINGLE-DOSE	20 ml					Historical
0456-0400-10	00456040010	10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01)		2010-10-29	0000-00-00	No	No	Current