Oxandrolone

Product NDC: 49884-301
Requested package NDC: 49884-301-01
11-digit product format: 498840301
Labeler code: 49884
Product ID: 49884-301_bb9cafda-1f4b-46ec-bf77-710def6c70de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxandrolone
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA077827
Marketing category: ANDA
Marketing start: 2007-08-20
Marketing end: 0000-00-00
Substance: OXANDROLONE
Active strength: 3 mg/1
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2023-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49884-301	49884-301-01	D	Discontinued by firm		2026-10-05

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 · 1 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-301	49884-301-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077827-001	OXANDROLONE	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22
A077827-002	OXANDROLONE	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22

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 · 86 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
2026-09-14 22:38:34	2026-08	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL			2007-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077827-002	OXANDROLONE	10MG	TABLET / ORAL			2007-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL	AB		2007-06-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077827-002	OXANDROLONE	10MG	TABLET / ORAL	AB	RS	2007-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL	AB		2007-06-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077827-002	OXANDROLONE	10MG	TABLET / ORAL	AB	RS	2007-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL	AB		2007-06-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077827-002	OXANDROLONE	10MG	TABLET / ORAL	AB	RS	2007-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077827-001	OXANDROLONE	2.5MG	TABLET / ORAL	AB		2007-06-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077827-002	OXANDROLONE	10MG	TABLET / ORAL	AB	RS	2007-06-22	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077827-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077827-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077827-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077827-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077827-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077827-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077827-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077827-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077827-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077827-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077827-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077827-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077827-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077827-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077827-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077827-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077827-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077827-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077827-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077827-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077827-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077827-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077827-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077827-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077827-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077827-002	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A077827-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077827-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077827-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077827-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077827-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077827-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077827-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077827-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077827-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077827-002	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c120320d-41f8-a983-c58c-6cb377b2756f	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-301-01	EA - Each	49884-301	8eaf5e8d-6960-4caa-ac79-687f0809a40d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXANDROLONE	ACTIVE INGREDIENT	7H6TM3CT4L	OXANDROLONE TABLET [PAR PHARMACEUTICAL INC.]	4
OXANDROLONE	ACTIVE MOIETY	7H6TM3CT4L	OXANDROLONE TABLET [PAR PHARMACEUTICAL INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXANDROLONE TABLET [PAR PHARMACEUTICAL INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXANDROLONE TABLET [PAR PHARMACEUTICAL INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXANDROLONE TABLET [PAR PHARMACEUTICAL INC.]	4
OXANDROLONE	ACTIVE INGREDIENT	7H6TM3CT4L	OXANDROLONE TABLET [AMERICAN HEALTH PACKAGING]	2
OXANDROLONE	ACTIVE MOIETY	7H6TM3CT4L	OXANDROLONE TABLET [AMERICAN HEALTH PACKAGING]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXANDROLONE TABLET [AMERICAN HEALTH PACKAGING]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXANDROLONE TABLET [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXANDROLONE TABLET [AMERICAN HEALTH PACKAGING]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXANDROLONE TABLET [AMERICAN HEALTH PACKAGING]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-301	OXANDROLONE TABLET [PAR PHARMACEUTICAL, INC.]	12	Legacy NDC	20230707_a6f42739-5bfc-4b76-8795-e93fa58f3d29.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7H6TM3CT4L	OXANDROLONE	53-39-4	OXANDROLONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198056	oxandrolone 2.5 MG Oral Tablet	PSN	7127ac16-f673-4b66-b5e5-5f881c85aa39	4
198056	oxandrolone 2.5 MG Oral Tablet	SCD	7127ac16-f673-4b66-b5e5-5f881c85aa39	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-301-01	49884030101	100 TABLET in 1 BOTTLE, PLASTIC (49884-301-01)	100 tablet	2007-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxandrolone Tablet, USP	Bryant Ranch Prepack	2022-04-29	HUMAN PRESCRIPTION DRUG LABEL	4
Oxandrolone Tablet, USP	Par Pharmaceutical, Inc. \| Par Pharmaceutical Inc.	2022-03-07	HUMAN PRESCRIPTION DRUG LABEL	12
Oxandrolone Tablets, USP CIII Rx Only 8242421/0717F	American Health Packaging	2019-02-26	HUMAN PRESCRIPTION DRUG LABEL	7