DRONABINOL

Product NDC
0527-4125
11-digit product format
005274125
Labeler code
0527
Product ID
0527-4125_aac4561c-b9ba-4d3a-b86c-be120e4593dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dronabinol
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA207421
Marketing category
ANDA
Marketing start
2020-02-10
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0527-4125DDiscontinued by firm2026-08-07
excluded packagepackage0527-41250527-4125-35DDiscontinued by firm2026-08-07

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a078d9db-810e-ade7-7f79-e8c1623628f9Product name420200617
03fbef77-e64f-4d6b-9d24-bfd1671e5179Product name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-4125-35DRONABINOL60 in 1 BOTTLECAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-4125DRONABINOL CAPSULE [LANNETT COMPANY, INC.]2Current NDC, Legacy NDC, 1 package rows20230929_c51d327b-51cc-408d-b0b3-fde5389294d0.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.

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197635droNABinol 2.5 MG Oral CapsulePSNc51d327b-51cc-408d-b0b3-fde5389294d02
197635dronabinol 2.5 MG Oral CapsuleSCDc51d327b-51cc-408d-b0b3-fde5389294d02
197635dronabinol 2.5 MG Oral CapsuleSYc51d327b-51cc-408d-b0b3-fde5389294d02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-4125-350052741253560 CAPSULE in 1 BOTTLE (0527-4125-35) 60 capsule2020-02-100000-00-00NoNoCurrent