CLAFORAN

Product NDC: 21586-031
11-digit product format: 215860031
Labeler code: 21586
Product ID: 21586-031_f03f3e64-fa62-4c69-a71e-086c58fc846f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefotaxime
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: SteriMax Inc.
Application: NDA050547
Marketing category: NDA
Marketing start: 2026-10-01
Substance: CEFOTAXIME SODIUM
Active strength: 1 g/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050547-001	CLAFORAN	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N050547-002	CLAFORAN	CEFOTAXIME SODIUM	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N050547-003	CLAFORAN	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N050547-004	CLAFORAN	CEFOTAXIME SODIUM	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-12-29

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050547-001	CLAFORAN	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050547-002	CLAFORAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050547-003	CLAFORAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050547-004	CLAFORAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050547-001	CLAFORAN	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050547-002	CLAFORAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050547-003	CLAFORAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050547-004	CLAFORAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050547-001	CLAFORAN	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050547-002	CLAFORAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050547-003	CLAFORAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050547-004	CLAFORAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050547-001	CLAFORAN	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050547-002	CLAFORAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050547-003	CLAFORAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050547-004	CLAFORAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050547-001	CLAFORAN	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050547-002	CLAFORAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050547-003	CLAFORAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050547-004	CLAFORAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050547-001	CLAFORAN	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050547-002	CLAFORAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050547-003	CLAFORAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050547-004	CLAFORAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050547-001	CLAFORAN	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050547-002	CLAFORAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050547-003	CLAFORAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050547-004	CLAFORAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050547-001	CLAFORAN	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050547-002	CLAFORAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050547-003	CLAFORAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050547-004	CLAFORAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050547-001	CLAFORAN	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050547-002	CLAFORAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050547-003	CLAFORAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050547-004	CLAFORAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050547-001	CLAFORAN	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050547-002	CLAFORAN	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050547-003	CLAFORAN	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050547-004	CLAFORAN	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-12-29	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: CLAFORAN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFOTAXIME SODIUM	1 g/1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
258J72S7TZ	CEFOTAXIME SODIUM	64485-93-4	CEFOTAXIME SODIUM
N2GI8B1GK7	CEFOTAXIME	63527-52-6	Cefotaxime

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
21586-031-02	21586003102	10 VIAL in 1 CARTON (21586-031-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (21586-031-01)	10 vial	2026-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLAFORAN - SteriMax Inc. \| Qilu Antibiotics Pharmaceutical Co., Ltd.	SteriMax Inc. \| Qilu Antibiotics Pharmaceutical Co., Ltd.	2026-08-14	HUMAN PRESCRIPTION DRUG LABEL	2