Home NDC 53097-573 MARINOL
Product NDC 53097-573
11-digit product format 530970573
Labeler code 53097
Product ID 53097-573_5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dronabinol
Dosage form CAPSULE
Route ORAL
Labeler ThePharmaNetwork, LLC
Application NDA018651
Marketing category NDA
Marketing start 2021-03-03
Substance DRONABINOL
Active strength 10 mg/1
Pharmacologic classes Cannabinoid [EPC], Cannabinoids [CS]
DEA schedule CIII
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018651-001 MARINOL DRONABINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 N018651-002 MARINOL DRONABINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 N018651-003 MARINOL DRONABINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base MARINOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DRONABINOL 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7J8897W37S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197634 Internal RxNorm lookup 197635 Internal RxNorm lookup 197636 Internal RxNorm lookup 205641 Internal RxNorm lookup 205642 Internal RxNorm lookup 205645 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 53097-573-60 MARINOL 60 in 1 BOTTLE CAPSULE 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53097-573 MARINOL (DRONABINOL) CAPSULE [THEPHARMANETWORK, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20230215_d0efeeec-640d-43c3-8f0a-d31324a11c68.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53097-573-60 53097057360 60 CAPSULE in 1 BOTTLE (53097-573-60) 60 capsule 2021-03-03 0000-00-00 No No Current