DRONABINOL

Product NDC
42291-449
Requested package NDC
42291-449-60
11-digit product format
422910449
Labeler code
42291
Product ID
42291-449_77794c6c-82e4-43d1-8126-b0776d80fa17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dronabinol
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA207421
Marketing category
ANDA
Marketing start
2020-03-16
Marketing end
0000-00-00
Substance
DRONABINOL
Active strength
3 mg/1
Pharmacologic classes
Cannabinoid [EPC],Cannabinoids [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42291-44942291-449-60DDiscontinued by firm2026-08-07

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207421-001DRONABINOLDRONABINOL2.5MGCAPSULE / ORALAB2020-02-07
A207421-002DRONABINOLDRONABINOL5MGCAPSULE / ORALAB2020-02-07
A207421-003DRONABINOLDRONABINOL10MGCAPSULE / ORALAB2020-02-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A207421-001AB
A207421-002AB
A207421-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207421-002DRONABINOL5MGCAPSULE / ORALAB2020-02-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207421-003DRONABINOL10MGCAPSULE / ORALAB2020-02-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207421-001DRONABINOL2.5MGCAPSULE / ORALAB2020-02-078072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207421-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207421-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207421-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207421-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207421-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207421-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207421-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207421-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207421-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207421-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207421-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207421-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207421-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207421-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207421-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207421-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207421-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207421-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207421-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207421-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207421-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207421-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207421-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207421-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207421-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207421-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207421-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207421-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207421-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207421-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207421-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207421-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207421-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207421-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207421-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207421-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207421-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207421-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207421-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207421-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-449-60EA - Each42291-449b2ea9832-2141-41fe-8c74-8840776c400612020-04-20

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRONABINOLDRONABINOLCamber Pharmaceuticals Inc66f36fe0-9808-4b73-a99a-794d86ff0c1c2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207421
application number: ANDA207421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-449-604229104496060 CAPSULE in 1 BOTTLE (42291-449-60) 60 capsule2020-03-160000-00-00NoNoCurrent