Home NDC 0025-1411 ARTHROTEC
Product NDC 0025-1411
11-digit product format 000251411
Labeler code 0025
Product ID 0025-1411_2b1bf1d7-4399-46bd-8654-2590513da5c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diclofenac sodium and misoprostol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA020607
Marketing category NDA
Marketing start 1997-12-24
Substance DICLOFENAC SODIUM; MISOPROSTOL
Active strength 50; 200 mg/1; ug/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020607-001 ARTHROTEC DICLOFENAC SODIUM; MISOPROSTOL 50MG;0.2MG TABLET, DELAYED RELEASE / ORAL AB RLD 1997-12-24 N020607-002 ARTHROTEC DICLOFENAC SODIUM; MISOPROSTOL 75MG;0.2MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 1997-12-24
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.
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 2026-08-01 22:54:32 2026-06 N020607-001 ARTHROTEC 50MG;0.2MG TABLET, DELAYED RELEASE / ORAL AB RLD 1997-12-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N020607-002 ARTHROTEC 75MG;0.2MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 1997-12-24 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N020607-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N020607-002 AB 1 a50c72e98297…
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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base ARTHROTEC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC SODIUM 50 mg/1 MISOPROSTOL 200 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0E43V0BB57 Internal UNII lookup QTG126297Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857706 Internal RxNorm lookup 1359105 Internal RxNorm lookup 1359107 Internal RxNorm lookup 1359109 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 0025-1411-60 ARTHROTEC 60 in 1 BOTTLE TABLET, FILM COATED 60 38 0025-1411-90 ARTHROTEC 90 in 1 BOTTLE TABLET, FILM COATED 90 38
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DICLOFENAC SODIUM ACTIVE INGREDIENT QTG126297Q ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 MISOPROSTOL ACTIVE INGREDIENT 0E43V0BB57 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 DICLOFENAC ACTIVE MOIETY 144O8QL0L1 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 MISOPROSTOL ACTIVE MOIETY 0E43V0BB57 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) INACTIVE INGREDIENT 74G4R6TH13 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 TALC INACTIVE INGREDIENT 7SEV7J4R1U ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 21 diclofenac sodium ACTIVE INGREDIENT QTG126297Q ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 misoprostol ACTIVE INGREDIENT 0E43V0BB57 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 diclofenac ACTIVE MOIETY 144O8QL0L1 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 misoprostol ACTIVE MOIETY 0E43V0BB57 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 crospovidone INACTIVE INGREDIENT 68401960MK ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 hydrogenated castor oil INACTIVE INGREDIENT ZF94AP8MEY ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 lactose INACTIVE INGREDIENT J2B2A4N98G ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 povidone K30 INACTIVE INGREDIENT U725QWY32X ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 starch, corn INACTIVE INGREDIENT O8232NY3SJ ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 talc INACTIVE INGREDIENT 7SEV7J4R1U ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5 triethyl citrate INACTIVE INGREDIENT 8Z96QXD6UM ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0025-1411 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 37 Current NDC, Legacy NDC, 2 package rows 20241205_600fe842-45d9-4d68-9ef2-456dbbebaa11.zip
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 0025-1411-60 00025141160 60 TABLET, FILM COATED in 1 BOTTLE (0025-1411-60) 1997-12-24 0000-00-00 No No Current 0025-1411-90 00025141190 90 TABLET, FILM COATED in 1 BOTTLE (0025-1411-90) 1997-12-24 0000-00-00 No No Current