Home NDC 49884-868 Dronabinol
Product NDC 49884-868
11-digit product format 498840868
Labeler code 49884
Product ID 49884-868_8e792359-de7f-4875-9834-0d74bd6066ed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dronabinol
Dosage form CAPSULE
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA078292
Marketing category ANDA
Marketing start 2008-06-27
Marketing end 0000-00-00
Substance DRONABINOL
Active strength 5 mg/1
Pharmacologic classes Cannabinoid [EPC],Cannabinoids [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A078292-001 DRONABINOL DRONABINOL 2.5MG CAPSULE / ORAL 2008-06-27 A078292-002 DRONABINOL DRONABINOL 5MG CAPSULE / ORAL 2008-06-27 A078292-003 DRONABINOL DRONABINOL 10MG CAPSULE / ORAL 2008-06-27
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 · 123 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 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL 2008-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078292-002 DRONABINOL 5MG CAPSULE / ORAL 2008-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078292-003 DRONABINOL 10MG CAPSULE / ORAL 2008-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL 2008-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078292-002 DRONABINOL 5MG CAPSULE / ORAL 2008-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078292-003 DRONABINOL 10MG CAPSULE / ORAL 2008-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL 2008-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078292-002 DRONABINOL 5MG CAPSULE / ORAL 2008-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078292-003 DRONABINOL 10MG CAPSULE / ORAL 2008-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL 2008-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078292-002 DRONABINOL 5MG CAPSULE / ORAL 2008-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078292-003 DRONABINOL 10MG CAPSULE / ORAL 2008-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL 2008-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078292-002 DRONABINOL 5MG CAPSULE / ORAL 2008-06-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078292-003 DRONABINOL 10MG CAPSULE / ORAL 2008-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL 2008-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078292-002 DRONABINOL 5MG CAPSULE / ORAL 2008-06-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078292-003 DRONABINOL 10MG CAPSULE / ORAL 2008-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL 2008-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078292-002 DRONABINOL 5MG CAPSULE / ORAL 2008-06-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078292-003 DRONABINOL 10MG CAPSULE / ORAL 2008-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL 2008-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078292-002 DRONABINOL 5MG CAPSULE / ORAL 2008-06-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078292-003 DRONABINOL 10MG CAPSULE / ORAL 2008-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL 2008-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078292-002 DRONABINOL 5MG CAPSULE / ORAL 2008-06-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078292-003 DRONABINOL 10MG CAPSULE / ORAL 2008-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL 2008-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078292-002 DRONABINOL 5MG CAPSULE / ORAL 2008-06-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078292-003 DRONABINOL 10MG CAPSULE / ORAL 2008-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2008-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078292-002 DRONABINOL 5MG CAPSULE / ORAL AB 2008-06-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078292-003 DRONABINOL 10MG CAPSULE / ORAL AB 2008-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2008-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078292-002 DRONABINOL 5MG CAPSULE / ORAL AB 2008-06-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078292-003 DRONABINOL 10MG CAPSULE / ORAL AB 2008-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2008-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078292-002 DRONABINOL 5MG CAPSULE / ORAL AB 2008-06-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078292-003 DRONABINOL 10MG CAPSULE / ORAL AB 2008-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078292-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2008-06-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 90 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DRONABINOL ACTIVE INGREDIENT 7J8897W37S DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 DRONABINOL ACTIVE MOIETY 7J8897W37S DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 AMMONIA INACTIVE INGREDIENT 5138Q19F1X DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 GELATIN INACTIVE INGREDIENT 2G86QN327L DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 SESAME OIL INACTIVE INGREDIENT QX10HYY4QV DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 SHELLAC INACTIVE INGREDIENT 46N107B71O DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R DRONABINOL CAPSULE [PAR PHARMACEUTICAL INC.] 5 DRONABINOL ACTIVE INGREDIENT 7J8897W37S DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 DRONABINOL ACTIVE INGREDIENT 7J8897W37S DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 DRONABINOL ACTIVE MOIETY 7J8897W37S DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 DRONABINOL ACTIVE MOIETY 7J8897W37S DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 AMMONIA INACTIVE INGREDIENT 5138Q19F1X DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 AMMONIA INACTIVE INGREDIENT 5138Q19F1X DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 SESAME OIL INACTIVE INGREDIENT QX10HYY4QV DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 SESAME OIL INACTIVE INGREDIENT QX10HYY4QV DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING] 3
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 49884-868-01 49884086801 100 CAPSULE in 1 BOTTLE (49884-868-01) 100 capsule 2008-06-27 0000-00-00 No No Current 49884-868-05 49884086805 500 CAPSULE in 1 BOTTLE (49884-868-05) 500 capsule 2008-06-27 0000-00-00 No No Current 49884-868-15 49884086815 25 CAPSULE in 1 BOTTLE (49884-868-15) 25 capsule 2008-06-27 0000-00-00 No No Current