Home NDC 63304-710 Ciprofloxacin
Product NDC 63304-710
11-digit product format 633040710
Labeler code 63304
Product ID 63304-710_aa0b6a4a-f8ff-4d09-8813-2d58192c08c5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciprofloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ranbaxy Pharmaceuticals Inc.
Application ANDA075747
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 E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record
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 2 · 110 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 RLD / RS Approval date A075747-001 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 A075747-002 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 A075747-003 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 2 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A075747-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075747-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A075747-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 c0c555d07b60…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63304-710-01 Ciprofloxacin 100 in 1 BOTTLE TABLET, FILM COATED 100 3 63304-710-05 Ciprofloxacin 500 in 1 BOTTLE TABLET, FILM COATED 500 3 63304-710-14 Ciprofloxacin 14 in 1 BOTTLE TABLET, FILM COATED 14 3 63304-710-80 Ciprofloxacin 100 in 1 BLISTER PACK TABLET, FILM COATED 100 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CIPROFLOXACIN HYDROCHLORIDE ACTIVE INGREDIENT 4BA73M5E37 CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 CIPROFLOXACIN ACTIVE MOIETY 5E8K9I0O4U CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-710 CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 Legacy NDC, 4 package rows 20130930_563e576e-6966-4f8d-91bb-0a1a951de324.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 63304-710-01 63304071001 100 in 1 BOTTLE Historical 63304-710-05 63304071005 500 in 1 BOTTLE Historical 63304-710-14 63304071014 14 in 1 BOTTLE Historical 63304-710-80 63304071080 100 in 1 BLISTER PACK Historical