Cefazolin

Product NDC: 67184-1001
11-digit product format: 671841001
Labeler code: 67184
Product ID: 67184-1001_0cc53b72-80e0-4a82-e063-6394a90a7fdf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefazolin
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Qilu Pharmaceutical Co., Ltd.
Application: ANDA203661
Marketing category: ANDA
Marketing start: 2015-12-28
Substance: CEFAZOLIN SODIUM
Active strength: 1 g/1
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 42.

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	Approval date
A203661-001	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28
A203661-002	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11
A203661-003	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203661-001	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 3 · 91 observed 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	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203661-002	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2022-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203661-003	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION		2024-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203661-001	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203661-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203661-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203661-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203661-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203661-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203661-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203661-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203661-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203661-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203661-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203661-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203661-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203661-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203661-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203661-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203661-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203661-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203661-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203661-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203661-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203661-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203661-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203661-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203661-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203661-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203661-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203661-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203661-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203661-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203661-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203661-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203661-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203661-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203661-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203661-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203661-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203661-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203661-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203661-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203661-001	AP	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P380M0454Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665050	Internal RxNorm lookup
1665060	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
e8bd9e95-8af5-416b-b58c-e1dbe3d052ac	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4c53c44d-0495-40c1-9f02-9d772dc7a5c7	Product name	1	20250318
53d47d5d-6076-4275-8f76-06d261cff1e8	Product name	1	20231011
9afe2d9a-f7f6-416b-9ddf-b780a2810bd5	Product name	1	20230912
6e62eeca-6666-f31f-9873-48ea9ede8354	Product name	2	20190214
afa25392-d76e-4453-8841-fde3a34824f1	Product name	2	20160309
53cae805-773b-4bc5-a836-3e22e250892e	Product name	1	20150922
05d4c919-c877-4ec4-cb08-9fcbbbfd8c70	Product name	1	20140508
75ba2549-0297-c880-16c8-4fa502c95a9d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67184-1001-2	Cefazolin	1 in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	1		7
67184-1001-2	Cefazolin	25 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	25		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67184-1001	CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.]	7	Current NDC, Legacy NDC, 2 package rows	20231219_e8bd9e95-8af5-416b-b58c-e1dbe3d052ac.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEFAZOLIN	CEFAZOLIN	Henry Schein, Inc.	5a8c4bb2-a75e-4d7d-91fb-9a95f04fc94b	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin	CEFAZOLIN	ProPharma Distribution	3d5cc73c-8a41-b285-e063-6294a90a609f	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin	CEFAZOLIN	Apotex Corp.	0422fe47-c372-494f-bac2-612f550b44a4	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin Sodium	CEFAZOLIN SODIUM	Direct_rx	22dfc2e4-07a7-8d13-e063-6394a90a3e9f	2024-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin	CEFAZOLIN	Qilu Pharmaceutical Co., Ltd.	e8bd9e95-8af5-416b-b58c-e1dbe3d052ac	2023-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661 ndc (product): 67184-1001
Cefazolin	CEFAZOLIN	Apotex Corp.	37a626aa-96dc-4c4d-bfbc-be4f328f918b	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin	CEFAZOLIN	Medical Purchasing Solutions, LLC	79787707-c84f-f229-e053-2a91aa0a1f16	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661
Cefazolin	CEFAZOLIN	Proficient Rx LP	d24529e3-e2b4-46d6-81ba-b7da74501792	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203661 application number: ANDA203661

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P380M0454Z	CEFAZOLIN SODIUM	27164-46-1	CEFAZOLIN SODIUM
IHS69L0Y4T	CEFAZOLIN	25953-19-9	Cefazolin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665050	ceFAZolin 1 GM Injection	PSN	e8bd9e95-8af5-416b-b58c-e1dbe3d052ac	7
1665060	ceFAZolin 2 GM Injection	PSN	e8bd9e95-8af5-416b-b58c-e1dbe3d052ac	7
1665050	cefazolin 1000 MG Injection	SCD	e8bd9e95-8af5-416b-b58c-e1dbe3d052ac	7
1665060	cefazolin 2000 MG Injection	SCD	e8bd9e95-8af5-416b-b58c-e1dbe3d052ac	7
1665060	cefazolin (as cefazolin sodium) 2 GM Injection	SY	e8bd9e95-8af5-416b-b58c-e1dbe3d052ac	7
1665050	cefazolin 1 GM (as cefazolin sodium) Injection	SY	e8bd9e95-8af5-416b-b58c-e1dbe3d052ac	7
1665050	cefazolin 1 GM Injection	SY	e8bd9e95-8af5-416b-b58c-e1dbe3d052ac	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67184-1001-2	67184100102	25 VIAL in 1 CARTON (67184-1001-2) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL	25 vial	2015-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefazolin for Injection, USP	Qilu Pharmaceutical Co., Ltd. \| Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)	2023-12-18	HUMAN PRESCRIPTION DRUG LABEL	7