FDA.reportPublic FDA data

Chloroquine Phosphate

Product NDC
50090-4967
Requested package NDC
50090-4967-3
11-digit product format
500904967
Labeler code
50090
Product ID
50090-4967_c1894997-1111-4e0f-8165-863f48026c89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chloroquine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091621
Marketing category
ANDA
Marketing start
2011-07-01
Marketing end
0000-00-00
Substance
CHLOROQUINE PHOSPHATE
Active strength
250 mg/1
Pharmacologic classes
Antimalarial [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-496750090-4967-3DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091621-001CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATE250MGTABLET / ORALAARS2011-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091621-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091621-001CHLOROQUINE PHOSPHATE250MGTABLET / ORALAARS2011-01-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091621-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chloroquine PhosphateCHLOROQUINE PHOSPHATERising Pharma Holdings, Inc.ee944d28-f596-4163-a502-e779c0d622bc2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091621
application number: ANDA091621

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4967-32023-02-07C16284748780-1f386c649-b05d-0266-e053-dadaa90a7c1aChloroquine Phosphate Tablet, USP
50090-4967-32023-01-30C16284748780-1f386c649-b05d-0266-e053-dadaa90a7c1aChloroquine Phosphate Tablet, USP

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4967-35009049670340 TABLET in 1 BOTTLE (50090-4967-3) 40 tablet2020-03-160000-00-00NoNoCurrent