Ciprofloxacin

Product NDC: 21695-914
11-digit product format: 216950914
Labeler code: 21695
Product ID: 21695-914_d4730085-b38e-43ce-bb51-2532da0a3e2b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Rebel Distributors Corp
Application: ANDA077245
Marketing category: ANDA
Marketing start: 2009-12-08
Marketing end: 0000-00-00
Substance: CIPROFLOXACIN
Active strength: 400 mg/40mL
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	21695-914		I	Inactivated by FDA		2026-08-03
excluded package	package	21695-914	21695-914-40	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
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	21695-914		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-914	21695-914-40	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	21695-914		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-914	21695-914-40	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	21695-914		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-914	21695-914-40	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	21695-914		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-914	21695-914-40	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	21695-914		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-914	21695-914-40	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	21695-914		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-914	21695-914-40	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	21695-914		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-914	21695-914-40	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	21695-914		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-914	21695-914-40	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	21695-914		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-914	21695-914-40	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	21695-914		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-914	21695-914-40	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	21695-914		I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-914	21695-914-40	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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
A077245-001	CIPROFLOXACIN	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION			2006-08-28
A077245-002	CIPROFLOXACIN	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION			2006-08-28

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	2006-08-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	2006-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077245-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077245-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		2006-08-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077245-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077245-002	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077245-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077245-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077245-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077245-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077245-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077245-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077245-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077245-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077245-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077245-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077245-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077245-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077245-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077245-002	AP	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
90aab9f8-63f3-478d-8db8-951525a18ab1	Product name	1	20180814
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
200e1d3d-46da-4371-beed-747da3cb3ff8	Product name	1	20180702
9e453f34-aacb-44d5-a119-c0e3dc1fca2a	Product name	1	20160622
01eecbfe-0b50-413b-8898-6905c89b6568	Product name	1	20151228
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
a3304bb6-ef4e-06df-d604-35f7e883ed6c	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
de5ea793-ffd9-0308-b0ca-00d9967be4ee	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-914-40	2019-09-24	C162847	48780-1	934fe258-4c59-48b1-e053-8cdaa90a720a	Ciprofloxacin Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-914-40	Ciprofloxacin	40 mL in 1 VIAL	INJECTION, SOLUTION, CONCENTRATE	40		1
21695-914-40	Ciprofloxacin	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-914-40	ML - Milliliter	21695-914	7929e55d-b22f-4ee1-a9f2-251c1f1ff89d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CIPROFLOXACIN	ACTIVE INGREDIENT	5E8K9I0O4U	CIPROFLOXACIN INJECTION, SOLUTION, CONCENTRATE [REBEL DISTRIBUTORS CORP]	1
CIPROFLOXACIN	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN INJECTION, SOLUTION, CONCENTRATE [REBEL DISTRIBUTORS CORP]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CIPROFLOXACIN INJECTION, SOLUTION, CONCENTRATE [REBEL DISTRIBUTORS CORP]	1
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	CIPROFLOXACIN INJECTION, SOLUTION, CONCENTRATE [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CIPROFLOXACIN INJECTION, SOLUTION, CONCENTRATE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-914	CIPROFLOXACIN INJECTION, SOLUTION, CONCENTRATE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110629_d4730085-b38e-43ce-bb51-2532da0a3e2b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5E8K9I0O4U	CIPROFLOXACIN	85721-33-1	CIPROFLOXACIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665229	ciprofloxacin 400 MG in 40 ML Injection	PSN	d4730085-b38e-43ce-bb51-2532da0a3e2b	1
1665229	40 ML ciprofloxacin 10 MG/ML Injection	SCD	d4730085-b38e-43ce-bb51-2532da0a3e2b	1
1665229	ciprofloxacin 400 MG per 40 ML Injection	SY	d4730085-b38e-43ce-bb51-2532da0a3e2b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-914-40	21695091440	40 mL in 1 VIAL	40 ml	Historical