ciprofloxacin

Product NDC
63187-142
11-digit product format
631870142
Labeler code
63187
Product ID
63187-142_91f426fc-3fc4-4c2f-a56d-10862e54d745
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076639
Marketing category
ANDA
Marketing start
2004-09-10
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076639-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10
A076639-002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10
A076639-003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076639-001AB
A076639-002AB
A076639-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-101e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076639-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076639-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076639-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076639-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076639-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076639-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076639-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076639-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076639-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076639-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076639-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076639-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-001AB11e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4BA73M5E37Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197511Internal RxNorm lookup
309309Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fbcd32c0-bcfd-4cc7-8e81-6612bc0cfc45Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-142-06ciprofloxacin06 in 1 BOTTLETABLET0614
63187-142-10ciprofloxacin10 in 1 BOTTLETABLET1014
63187-142-14ciprofloxacin14 in 1 BOTTLETABLET1414
63187-142-20ciprofloxacin20 in 1 BOTTLETABLET2014
63187-142-28ciprofloxacin28 in 1 BOTTLETABLET2814
63187-142-30ciprofloxacin30 in 1 BOTTLETABLET3014
63187-142-60ciprofloxacin60 in 1 BOTTLETABLET6014
63187-142-90ciprofloxacin90 in 1 BOTTLETABLET9014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET [PROFICIENT RX LP]6
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET [PROFICIENT RX LP]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET [PROFICIENT RX LP]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIPROFLOXACIN TABLET [PROFICIENT RX LP]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET [PROFICIENT RX LP]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET [PROFICIENT RX LP]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET [PROFICIENT RX LP]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET [PROFICIENT RX LP]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET [PROFICIENT RX LP]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET [PROFICIENT RX LP]6
WATERINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN TABLET [PROFICIENT RX LP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-142CIPROFLOXACIN TABLET [PROFICIENT RX LP]14Current NDC, Legacy NDC, 8 package rows20220609_fbcd32c0-bcfd-4cc7-8e81-6612bc0cfc45.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ciprofloxacinCIPROFLOXACINNorthwind Health Company, LLC4deea61e-f3ca-b35d-e063-6294a90a9d412026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINCardinal Health 107, LLC922e9f5c-cc59-4d9e-bf42-a4b900d077ed2026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINMajor Pharmaceuticalsf818ed31-c746-4171-afdf-57a75434e5f12026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINQPharma, Inc.4149d980-a6cd-c06d-e063-6394a90a47a12025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINRising Pharma Holdings, Inc.ef468722-68cd-440b-afd7-2285029db41f2025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.2491e6a9-3415-43b9-b31b-67331f52806a2025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.e81341c6-0e25-4860-adda-2d3cebe88d622025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.178dc379-e2b8-4b47-9f0c-3fc7fb435c362025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINA-S Medication Solutionsc12b316f-811c-48b6-a320-d314991aa74f2025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINBryant Ranch Prepack69df48cc-76b6-428e-891a-c25e07d785f82025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINBryant Ranch Prepacka5ecc693-b8fd-4a7a-8040-e56f801c93532025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINCoupler LLC2fff7a38-2c4e-d343-e063-6294a90aca3c2025-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINUmasuto, LLC0c355077-7361-41d0-9e82-eb31beaf5daa2025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals, Inc.44e5582d-fff1-0ec9-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals, Inc.46dedf2c-26de-0f46-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.641729a3-6dd3-3a2f-e053-2991aa0a015e2024-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.5bab9397-b9f3-d309-e053-2991aa0a66122024-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINA-S Medication Solutions6971a958-08f0-4712-bf5f-47fe4f76b8632023-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPharmPak, Inc.e2902d14-16bb-46a9-a45a-4f1f9b0ecf4a2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPharmPak, Inc.6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc4514
309309ciprofloxacin 500 MG Oral TabletPSNfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc4514
197511ciprofloxacin 250 MG Oral TabletSCDfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc4514
309309ciprofloxacin 500 MG Oral TabletSCDfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc4514
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc4514
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc4514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-142-06631870142066 TABLET in 1 BOTTLE (63187-142-06) 6 tablet2014-08-010000-00-00NoNoCurrent
63187-142-106318701421010 TABLET in 1 BOTTLE (63187-142-10) 10 tablet2014-08-010000-00-00NoNoCurrent
63187-142-146318701421414 TABLET in 1 BOTTLE (63187-142-14) 14 tablet2014-08-010000-00-00NoNoCurrent
63187-142-206318701422020 TABLET in 1 BOTTLE (63187-142-20) 20 tablet2014-08-010000-00-00NoNoCurrent
63187-142-286318701422828 TABLET in 1 BOTTLE (63187-142-28) 28 tablet2014-08-010000-00-00NoNoCurrent
63187-142-306318701423030 TABLET in 1 BOTTLE (63187-142-30) 30 tablet2021-07-230000-00-00NoNoCurrent
63187-142-606318701426060 TABLET in 1 BOTTLE (63187-142-60) 60 tablet2021-07-230000-00-00NoNoCurrent
63187-142-906318701429090 TABLET in 1 BOTTLE (63187-142-90) 90 tablet2021-07-230000-00-00NoNoCurrent