Home NDC 53097-571 MARINOL
Product NDC 53097-571
11-digit product format 530970571
Labeler code 53097
Product ID 53097-571_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 2.5 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product 53097-571 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53097-571 53097-571-60 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
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-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.
Product history page 1 of 4 · 126 observed 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 2026-08-18 06:07:40 2026-07 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018651-002 MARINOL 5MG CAPSULE / ORAL AB RLD, RS 1985-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018651-003 MARINOL 10MG CAPSULE / ORAL AB RLD 1985-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018651-001 MARINOL 2.5MG CAPSULE / ORAL AB RLD 1985-05-31 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base MARINOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DRONABINOL 2.5 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 53097-571-60 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 53097-571 MARINOL (DRONABINOL) CAPSULE [THEPHARMANETWORK, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20230215_d0efeeec-640d-43c3-8f0a-d31324a11c68.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 1 · 4 matching rows.
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 53097-571-60 53097057160 60 CAPSULE in 1 BOTTLE (53097-571-60) 60 capsule 2021-03-03 0000-00-00 No No Current