Home NDC 31722-962 DRONABINOL
Product NDC 31722-962
11-digit product format 317220962
Labeler code 31722
Product ID 31722-962_dd59cbf6-b383-4c39-ae06-2c7ea4de966a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dronabinol
Dosage form CAPSULE
Route ORAL
Labeler Camber Pharmaceuticals Inc
Application ANDA207421
Marketing category ANDA
Marketing start 2020-02-10
Substance DRONABINOL
Active strength 10 mg/1
Pharmacologic classes Cannabinoid [EPC], Cannabinoids [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2027-12-31
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 A207421-001 DRONABINOL DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 A207421-002 DRONABINOL DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 A207421-003 DRONABINOL DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07
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 3 · 111 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 2026-02-19 14:30 UTC 2026-02 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DRONABINOL
Listing expiration 2027-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197634 Internal RxNorm lookup 197635 Internal RxNorm lookup 197636 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 31722-962-60 DRONABINOL 60 in 1 BOTTLE CAPSULE 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-962 DRONABINOL CAPSULE [CAMBER PHARMACEUTICALS INC] 3 Current NDC, Legacy NDC, 1 package rows 20200317_66f36fe0-9808-4b73-a99a-794d86ff0c1c.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 · 1 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 31722-962-60 31722096260 60 CAPSULE in 1 BOTTLE (31722-962-60) 60 capsule 2020-02-10 0000-00-00 No No Current