FDA.reportPublic FDA data

Diclofenac Sodium and Misoprostol Delayed-Release

Product NDC
63126-342
11-digit product format
631260342
Labeler code
63126
Product ID
63126-342_8292f0dd-d941-43ec-aae0-6f29ef1c84e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium and Misoprostol
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Yung Shin Pharmaceutical Industrual Co., Ltd.
Application
ANDA205143
Marketing category
ANDA
Marketing start
2020-06-30
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM; MISOPROSTOL
Active strength
75 mg/1; ug/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205143-001DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2020-02-19
A205143-002DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2020-02-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A205143-001AB
A205143-002AB

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 22:54:322026-06A205143-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2020-02-19a50c72e98297…
2026-08-01 22:54:322026-06A205143-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2020-02-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205143-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205143-002AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepack6865a5cf-3263-44b5-96d9-7a7a4c6e1c052026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205143
application number: ANDA205143
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepackde4c02a5-87e8-42f5-a9ff-f409ff9e6d622026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205143
application number: ANDA205143
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepack6f9684f7-f39a-4f5e-9fd4-ed140fae206b2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205143
application number: ANDA205143
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLNivagen Pharmaceuticals, Inc.2acf46ac-8ba8-444d-b421-19d5ad49644c2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205143
application number: ANDA205143
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLProficient Rx LP33f7db0b-f049-4d2e-abf5-4db97222e1752022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205143
application number: ANDA205143