Fosfomycin Tromethamine

Product NDC: 67877-749
11-digit product format: 678770749
Labeler code: 67877
Product ID: 67877-749_0ebb79a9-df22-4fec-b872-b020b5129b14
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosfomycin Tromethamine
Dosage form: GRANULE, FOR SOLUTION
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA214554
Marketing category: ANDA
Marketing start: 2021-10-22
Substance: FOSFOMYCIN TROMETHAMINE
Active strength: 3 g/1
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214554-001	FOSFOMYCIN TROMETHAMINE	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA		2021-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214554-001	AA

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214554-001	FOSFOMYCIN TROMETHAMINE	EQ 3GM BASE/PACKET	FOR SOLUTION / ORAL	AA	2021-10-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214554-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214554-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214554-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214554-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214554-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214554-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214554-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214554-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214554-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214554-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214554-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214554-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214554-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214554-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214554-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214554-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214554-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214554-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214554-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214554-001	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214554-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214554-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214554-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214554-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214554-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214554-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214554-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214554-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214554-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214554-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214554-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214554-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214554-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214554-001	AA	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FOSFOMYCIN TROMETHAMINE	3 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7FXW6U30GY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
808917	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
48e352bc-52ea-4778-905a-60ef38a5c18a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
71a697a3-5c0d-49b7-8ae7-06ff4c989d95	Product name	4	20250128

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67877-749-57	Fosfomycin Tromethamine	1 in 1 CARTON	GRANULE, FOR SOLUTION	1		5
67877-749-57	Fosfomycin Tromethamine	1 in 1 PACKET	GRANULE, FOR SOLUTION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-749-57	EA - Each	67877-749	9a42e981-7f4b-4d01-aeef-50d2d9523359	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-749	FOSFOMYCIN TROMETHAMINE GRANULE, FOR SOLUTION [ASCEND LABORATORIES, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20220915_48e352bc-52ea-4778-905a-60ef38a5c18a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosfomycin Tromethamine	FOSFOMYCIN TROMETHAMINE	Ascend Laboratories, LLC	48e352bc-52ea-4778-905a-60ef38a5c18a	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214554 application number: ANDA214554 ndc (product): 67877-749
Fosfomycin Tromethamine	FOSFOMYCIN TROMETHAMINE	Kesin Pharma Corporation	3fa61bd4-fc55-0987-e063-6394a90abce2	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214554 application number: ANDA214554
Fosfomycin Tromethamine	FOSFOMYCIN TROMETHAMINE	A-S Medication Solutions	6b9167a9-80e9-44e1-a609-c3eb78960acf	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214554 application number: ANDA214554

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7FXW6U30GY	FOSFOMYCIN TROMETHAMINE	78964-85-9	FOSFOMYCIN TROMETHAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
808917	fosfomycin 3 GM Granules for Oral Solution	PSN	48e352bc-52ea-4778-905a-60ef38a5c18a	5
808917	fosfomycin 3 GM Granules for Oral Solution	PSN	6b9167a9-80e9-44e1-a609-c3eb78960acf	5
808917	fosfomycin 3000 MG Granules for Oral Solution	SCD	48e352bc-52ea-4778-905a-60ef38a5c18a	5
808917	fosfomycin 3000 MG Granules for Oral Solution	SCD	6b9167a9-80e9-44e1-a609-c3eb78960acf	5
808917	fosfomycin (as fosfomycin tromethamine) 3000 MG Granules for Oral Solution	SY	48e352bc-52ea-4778-905a-60ef38a5c18a	5
808917	fosfomycin (as fosfomycin tromethamine) 3000 MG Granules for Oral Solution	SY	6b9167a9-80e9-44e1-a609-c3eb78960acf	5
808917	fosfomycin 3 GM Granules for Oral Solution	SY	48e352bc-52ea-4778-905a-60ef38a5c18a	5
808917	fosfomycin 3 GM Granules for Oral Solution	SY	6b9167a9-80e9-44e1-a609-c3eb78960acf	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-749-57	67877074957	1 PACKET in 1 CARTON (67877-749-57) / 1 GRANULE, FOR SOLUTION in 1 PACKET	1 packet	2021-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fosfomycin Tromethamine Granules for Oral Solution Rx only	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2025-12-17	Human Prescription Drug Label	5
Fosfomycin Tromethamine Granules for Oral Solution Rx only	Bryant Ranch Prepack	2024-01-12	HUMAN PRESCRIPTION DRUG LABEL	101
Fosfomycin Tromethamine Granules for Oral Solution Rx only	A-S Medication Solutions	2023-11-01	Human Prescription Drug Label	5