Ciprofloxacin

Product NDC: 12634-769
11-digit product format: 126340769
Labeler code: 12634
Product ID: 12634-769_27310a8d-5bb6-4624-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA076558
Marketing category: ANDA
Marketing start: 2004-06-09
Marketing end: 0000-00-00
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 18 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-769		I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-00	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-01	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-54	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-57	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-59	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-61	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-66	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-67	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-71	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-74	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-78	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-80	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-84	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-85	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-91	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-96	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-769	12634-769-98	I	Inactivated by FDA	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 7 · 378 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-769-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-74	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-84	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-769-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-54	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-74	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-84	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-67	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-66	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-98	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-769-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-769-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-769-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-769-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-769-59	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-769-54	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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	Approval date
A076558-002	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09
A076558-003	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09
A076558-004	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09

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 4 · 126 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	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL		2004-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL		2004-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL		2004-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076558-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076558-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076558-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076558-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076558-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076558-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076558-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076558-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076558-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076558-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076558-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076558-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076558-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076558-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076558-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076558-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076558-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076558-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076558-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076558-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076558-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076558-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076558-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076558-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076558-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076558-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076558-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076558-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076558-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076558-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076558-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076558-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076558-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076558-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076558-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076558-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076558-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076558-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076558-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076558-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076558-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076558-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076558-002	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
90aab9f8-63f3-478d-8db8-951525a18ab1	Product name	1	20180814
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
12634-769-00	Ciprofloxacin Tablets, USP
12634-769-01	Ciprofloxacin Tablets, USP
12634-769-54	Ciprofloxacin Tablets, USP
12634-769-57	Ciprofloxacin Tablets, USP
12634-769-59	Ciprofloxacin Tablets, USP
12634-769-61	Ciprofloxacin Tablets, USP
12634-769-66	Ciprofloxacin Tablets, USP
12634-769-67	Ciprofloxacin Tablets, USP
12634-769-71	Ciprofloxacin Tablets, USP
12634-769-74	Ciprofloxacin Tablets, USP
12634-769-78	Ciprofloxacin Tablets, USP
12634-769-80	Ciprofloxacin Tablets, USP
12634-769-84	Ciprofloxacin Tablets, USP
12634-769-85	Ciprofloxacin Tablets, USP
12634-769-91	Ciprofloxacin Tablets, USP
12634-769-96	Ciprofloxacin Tablets, USP
12634-769-98	Ciprofloxacin Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-769-00	Ciprofloxacin	10 in 1 BOTTLE	TABLET, FILM COATED	10	1
12634-769-01	Ciprofloxacin	100 in 1 BOTTLE	TABLET, FILM COATED	100	1
12634-769-54	Ciprofloxacin	14 in 1 BLISTER PACK	TABLET, FILM COATED	14	1
12634-769-57	Ciprofloxacin	20 in 1 BLISTER PACK	TABLET, FILM COATED	20	1
12634-769-59	Ciprofloxacin	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	1
12634-769-61	Ciprofloxacin	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	1
12634-769-66	Ciprofloxacin	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	1
12634-769-67	Ciprofloxacin	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	1
12634-769-71	Ciprofloxacin	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
12634-769-74	Ciprofloxacin	24 in 1 BOTTLE	TABLET, FILM COATED	24	1
12634-769-78	Ciprofloxacin	28 in 1 BOTTLE	TABLET, FILM COATED	28	1
12634-769-80	Ciprofloxacin	20 in 1 BOTTLE	TABLET, FILM COATED	20	1
12634-769-84	Ciprofloxacin	14 in 1 BOTTLE	TABLET, FILM COATED	14	1
12634-769-85	Ciprofloxacin	15 in 1 BOTTLE	TABLET, FILM COATED	15	1
12634-769-91	Ciprofloxacin	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	1
12634-769-96	Ciprofloxacin	6 in 1 BOTTLE	TABLET, FILM COATED	6	1
12634-769-98	Ciprofloxacin	8 in 1 BOTTLE	TABLET, FILM COATED	8	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-769	CIPROFLOXACIN TABLET, FILM COATED [APOTHECA INC.]	1	Legacy NDC, 17 package rows	20151218_2730ec3d-e1a4-3cbc-e054-00144ff8d46c.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFLOXACIN	REMEDYREPACK INC.	44b6cefc-7638-4437-95e7-8f239f66a9d4	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	REMEDYREPACK INC.	c08b37c3-5f01-47ed-9508-02813bbd008b	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	3b9b15f7-354b-4049-982b-f6f31751a885	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	Northwind Health Company, LLC	f67d727f-b9ca-aec0-e053-2995a90aab69	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	fa32aafd-e3f5-4be6-9413-c7663c1c2cec	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	5723eaf9-8659-4730-b792-4e4c33690ccb	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	d275175c-691a-4d09-bbb7-50ee819e6727	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
CIPROFLOXACIN	CIPROFLOXACIN	DirectRx	d23e359d-6d12-38f6-e053-2a95a90a0a88	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	DirectRx	d358eb18-f4d0-e9ba-e053-2a95a90a435d	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	Golden State Medical Supply, Inc.	2e1addcf-6d5b-46c8-812b-558fd847f005	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	Hikma Pharmaceuticals USA Inc.	3b3d22dc-df09-4910-8c9b-1204eeedbd68	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	4f600112-168a-4a58-9914-7c01f71894da	2024-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	a57066d7-dc2c-d2d0-b003-d9143fcca1c5	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558
Ciprofloxacin	CIPROFLOXACIN	Asclemed USA, Inc.	1bb1d26e-fad0-4338-8948-3f095d5817a6	2022-03-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076558 application number: ANDA076558

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4BA73M5E37	CIPROFLOXACIN HYDROCHLORIDE	86393-32-0	CIPROFLOXACIN HYDROCHLORIDE
5E8K9I0O4U	CIPROFLOXACIN	85721-33-1	Ciprofloxacin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309309	ciprofloxacin 500 MG Oral Tablet	PSN	2730ec3d-e1a4-3cbc-e054-00144ff8d46c	1
309309	ciprofloxacin 500 MG Oral Tablet	SCD	2730ec3d-e1a4-3cbc-e054-00144ff8d46c	1
309309	ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet	SY	2730ec3d-e1a4-3cbc-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-769-00	12634076900	10 in 1 BOTTLE	Historical
12634-769-01	12634076901	100 in 1 BOTTLE	Historical
12634-769-54	12634076954	14 in 1 BLISTER PACK	Historical
12634-769-57	12634076957	20 in 1 BLISTER PACK	Historical
12634-769-59	12634076959	30 in 1 BLISTER PACK	Historical
12634-769-61	12634076961	10 in 1 BLISTER PACK	Historical
12634-769-66	12634076966	6 in 1 BLISTER PACK	Historical
12634-769-67	12634076967	7 in 1 BLISTER PACK	Historical
12634-769-71	12634076971	30 in 1 BOTTLE	Historical
12634-769-74	12634076974	24 in 1 BOTTLE	Historical
12634-769-78	12634076978	28 in 1 BOTTLE	Historical
12634-769-80	12634076980	20 in 1 BOTTLE	Historical
12634-769-84	12634076984	14 in 1 BOTTLE	Historical
12634-769-85	12634076985	15 in 1 BOTTLE	Historical
12634-769-91	12634076991	1 in 1 BLISTER PACK	Historical
12634-769-96	12634076996	6 in 1 BOTTLE	Historical
12634-769-98	12634076998	8 in 1 BOTTLE	Historical