Home NDC 50419-754 Cipro
Product NDC 50419-754
11-digit product format 504190754
Labeler code 50419
Product ID 50419-754_1b112839-6cf0-466a-9188-86fc5b1549f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciprofloxacin hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bayer HealthCare Pharmaceuticals Inc.
Application NDA019537
Marketing category NDA
Marketing start 1987-10-22
Substance CIPROFLOXACIN HYDROCHLORIDE
Active strength 500 mg/1
Pharmacologic classes Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [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 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 RLD / RS Approval date N019537-002 CIPRO CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 N019537-003 CIPRO CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 N019537-004 CIPRO CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 156 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 2026-08-18 06:07:40 2026-07 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019537-001 CIPRO EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019537-001 CIPRO EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cipro
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIPROFLOXACIN HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4BA73M5E37 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197511 Internal RxNorm lookup 205769 Internal RxNorm lookup 205770 Internal RxNorm lookup 213224 Internal RxNorm lookup 213226 Internal RxNorm lookup 309308 Internal RxNorm lookup 309309 Internal RxNorm lookup 309310 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50419-754-01 Cipro 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 32
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CIPROFLOXACIN HYDROCHLORIDE ACTIVE INGREDIENT 4BA73M5E37 CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 CIPROFLOXACIN ACTIVE MOIETY 5E8K9I0O4U CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) INACTIVE INGREDIENT 74G4R6TH13 CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 POVIDONES INACTIVE INGREDIENT FZ989GH94E CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 SUCROSE INACTIVE INGREDIENT C151H8M554 CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15 WATER INACTIVE INGREDIENT 059QF0KO0R CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-754 CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 30 Current NDC, Legacy NDC, 1 package rows 20241218_888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cipro CIPROFLOXACIN HYDROCHLORIDE Bayer HealthCare Pharmaceuticals Inc. 888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0 2026-03-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019537 application number: NDA019537 ndc (product): 50419-754
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50419-754-01 50419075401 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-754-01) 1987-10-22 0000-00-00 No No Current