ARMODAFINIL

Product NDC: 72189-133
11-digit product format: 721890133
Labeler code: 72189
Product ID: 72189-133_2c28fdcb-8329-f51c-e063-6394a90a2fe2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ARMODAFINIL
Dosage form: TABLET
Route: ORAL
Labeler: direct rx
Application: ANDA206069
Marketing category: ANDA
Marketing start: 2020-10-15
Substance: ARMODAFINIL
Active strength: 250 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206069-001	ARMODAFINIL	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06
A206069-002	ARMODAFINIL	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06
A206069-003	ARMODAFINIL	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06
A206069-004	ARMODAFINIL	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A206069-001	AB
A206069-002	AB
A206069-003	AB
A206069-004	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A206069-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206069-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206069-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2018-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206069-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2018-12-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A206069-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206069-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206069-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206069-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Caldesene Baby	STARCH, CORN AND ZINC OXIDE	Insight Pharmaceuticals LLC	9f12dee2-7afa-45e9-a729-0fd42bb77715	2026-04-22	Warnings	Exact identifier unii: O8232NY3SJ
Caldesene Medicated Protecting	CORNSTARCH AND ZINC OXIDE	Insight Pharmaceuticals LLC	ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b	2026-04-22	Warnings	Exact identifier unii: O8232NY3SJ
Armodafinil	ARMODAFINIL	Preferred Pharmaceuticals Inc.	93b9f9a4-66d9-4ed9-8f2f-903e416e900d	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206069 application number: ANDA206069 ndc (package): 68788-7826-9 ndc (package): 68788-7826-6 ndc (package): 68788-7826-3 ndc (product): 68788-7826 rxcui: 861960 spl id: 8f3858c1-8fd9-49cf-a1fa-e4d11d4ce86b spl set id: 93b9f9a4-66d9-4ed9-8f2f-903e416e900d unii: V63XWA605I
Armodafinil	ARMODAFINIL	Preferred Pharmaceuticals Inc.	4128759d-ed7c-4130-b24c-a0541f2b9e7f	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206069 application number: ANDA206069 ndc (package): 68788-7880-3 ndc (package): 68788-7880-6 ndc (package): 68788-7880-9 ndc (product): 68788-7880 rxcui: 724859 spl id: da87ba1c-5887-4492-8ae9-40a027d5e449 spl set id: 4128759d-ed7c-4130-b24c-a0541f2b9e7f unii: V63XWA605I
Armodafinil	ARMODAFINIL	Bryant Ranch Prepack	58e33a21-7816-4fa9-9fc7-c559426ad2b9	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: ANDA200043 ndc (package): 71335-2991-3 ndc (package): 71335-2991-1 ndc (package): 71335-2991-2 ndc (product): 71335-2991 rxcui: 724859 spl id: 7e8152cc-4061-4276-8843-a06cbfb5b1bf spl set id: 58e33a21-7816-4fa9-9fc7-c559426ad2b9 unii: V63XWA605I
Lotrimin Daily Sweat and Odor Control	TOPICAL STARCH	Bayer HealthCare LLC.	9ec5c80d-b550-496f-e053-2a95a90a5489	2026-01-16	Warnings	Exact identifier unii: O8232NY3SJ
Medicated Cornstarch Baby Powder	ACTIVE CORN STARCH	Davion, Inc.	e39032d1-c8cd-4a41-af10-126970b8ad38	2025-12-29	Warnings	Exact identifier unii: O8232NY3SJ
Nuvigil	ARMODAFINIL	Golden State Medical Supply, Inc.	3dd49302-f757-d945-e063-6294a90afcba	2025-09-02	Warnings, Adverse reactions	Exact identifier application number: NDA021875 ndc (package): 60429-001-30 ndc (package): 60429-004-30 ndc (package): 60429-002-30 ndc (package): 60429-003-30 ndc (product): 60429-001 ndc (product): 60429-004 ndc (product): 60429-003 ndc (product): 60429-002 rxcui: 724863 rxcui: 724859 rxcui: 724861 rxcui: 861962 rxcui: 861960 rxcui: 805661 rxcui: 805659 rxcui: 805663 spl id: 3dd48c06-8784-6926-e063-6294a90a7590 spl set id: 3dd49302-f757-d945-e063-6294a90afcba unii: V63XWA605I
Nuvigil	ARMODAFINIL	Apotex Corp.	a69631d0-1263-769e-b232-4ab9160e0fa3	2025-08-18	Warnings, Adverse reactions	Exact identifier application number: NDA021875 ndc (package): 60505-4846-3 ndc (package): 60505-4850-3 ndc (package): 60505-4847-3 ndc (package): 60505-4849-3 ndc (product): 60505-4846 ndc (product): 60505-4849 ndc (product): 60505-4850 ndc (product): 60505-4847 rxcui: 724863 rxcui: 724859 rxcui: 724861 rxcui: 861962 rxcui: 861960 rxcui: 805661 rxcui: 805659 rxcui: 805663 spl id: ab761afd-b864-a5f9-e204-952c98103e63 spl set id: a69631d0-1263-769e-b232-4ab9160e0fa3 unii: V63XWA605I
YVTYVT MICRODERMABRASION FACIAL SCRUB	YVTYVT MICRODERMABRASION FACIAL SCRUB	Beijing JUNGE Technology Co., Ltd.	2f30fc45-42e2-c766-e063-6394a90a8d68	2025-02-28	Warnings	Exact identifier unii: OP1R32D61U
ARMODAFINIL	ARMODAFINIL	DirectRx	ddd06dab-0855-5b4e-e053-2a95a90a5e67	2025-01-22	Warnings, Adverse reactions	Exact identifier application number: NDA021875 ndc (package): 72189-353-30 ndc (product): 72189-353 rxcui: 861960 spl id: 2c4c8cee-041f-c5ef-e063-6394a90a8cfd spl set id: ddd06dab-0855-5b4e-e053-2a95a90a5e67 unii: V63XWA605I
Armodafinil	ARMODAFINIL	Direct_Rx	facd329b-1925-61df-e053-6294a90ab738	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206069 application number: ANDA206069 ndc (package): 72189-464-30 ndc (product): 72189-464 rxcui: 724863 spl id: 2c4dd8aa-05cd-69f7-e063-6294a90abcd1 spl set id: facd329b-1925-61df-e053-6294a90ab738 unii: V63XWA605I
ARMODAFINIL	ARMODAFINIL	direct rx	b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206069 application number: NDA021875 application number: ANDA206069 ndc (package): 72189-261-30 ndc (package): 72189-133-30 ndc (product): 72189-133 ndc (product): 72189-261 rxcui: 724861 spl id: 2c28fdcb-8329-f51c-e063-6394a90a2fe2 spl set id: b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19 unii: V63XWA605I
Armodafinil	ARMODAFINIL	Quality Care Products LLC	98338994-7818-4b86-ae98-cd08fa700879	2024-12-17	Warnings, Adverse reactions	Exact identifier application number: NDA021875 ndc (package): 55700-510-30 ndc (product): 55700-510 rxcui: 724861 spl id: 5e8316d5-1f2c-487b-8053-5507eecee36a spl set id: 98338994-7818-4b86-ae98-cd08fa700879 unii: V63XWA605I
Armodafinil	ARMODAFINIL	Bryant Ranch Prepack	cbe7c0d9-dfd2-4000-bd76-7fe3454ce64f	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206069 application number: ANDA206069 ndc (package): 71335-1193-1 ndc (package): 71335-1308-3 ndc (package): 71335-1193-3 ndc (package): 71335-1308-1 ndc (package): 71335-1308-2 ndc (package): 71335-1193-2 ndc (product): 71335-1193 ndc (product): 71335-1308 rxcui: 724859 rxcui: 724861 spl id: 0c5145ed-6785-4545-b59e-dc5ba22a07dc spl set id: cbe7c0d9-dfd2-4000-bd76-7fe3454ce64f unii: V63XWA605I
Pure Cornstarch Baby	CORN STARCH	Walgreen Company	d0e9bd13-b568-4f7e-b036-8d23e71ad8bf	2024-03-25	Warnings	Exact identifier unii: O8232NY3SJ
Armodafinil	ARMODAFINIL	Aurobindo Pharma Limited	23da56b8-7552-4362-a1ab-e794c131194c	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206069 application number: ANDA206069 ndc (package): 65862-805-60 ndc (package): 65862-805-05 ndc (package): 65862-806-05 ndc (package): 65862-807-05 ndc (package): 65862-807-30 ndc (package): 65862-806-30 ndc (package): 65862-806-60 ndc (package): 65862-807-60 ndc (package): 65862-805-30 ndc (package): 65862-998-30 ndc (product): 65862-805 ndc (product): 65862-998 ndc (product): 65862-807 ndc (product): 65862-806 rxcui: 724863 rxcui: 724859 rxcui: 724861 rxcui: 861960 spl id: 09746c0a-9656-4f1d-a380-1cbe732c8e21 spl set id: 23da56b8-7552-4362-a1ab-e794c131194c unii: V63XWA605I
Armodafinil	ARMODAFINIL	Natco Pharma USA LLC	de2f0921-e791-426c-9192-2b7162e2158c	2023-12-05	Warnings, Adverse reactions	Exact identifier application number: ANDA202768 ndc (package): 69339-178-03 ndc (package): 69339-178-10 ndc (package): 69339-179-10 ndc (package): 69339-177-10 ndc (package): 69339-180-03 ndc (package): 69339-177-03 ndc (package): 69339-180-05 ndc (package): 69339-179-03 ndc (product): 69339-178 ndc (product): 69339-180 ndc (product): 69339-177 ndc (product): 69339-179 rxcui: 724863 rxcui: 724859 rxcui: 724861 rxcui: 861960 spl id: d93dca81-a0da-49ee-be61-86e713ab56cd spl set id: de2f0921-e791-426c-9192-2b7162e2158c unii: V63XWA605I
Armodafinil	ARMODAFINIL	Teva Pharmaceuticals USA, Inc.	b3cac300-c3d2-4189-a410-2aaf3773c090	2023-01-31	Warnings, Adverse reactions	Exact identifier application number: NDA021875 ndc (package): 0093-3093-56 ndc (package): 0093-3092-56 ndc (package): 0093-3094-56 ndc (package): 0093-3090-56 ndc (product): 0093-3092 ndc (product): 0093-3094 ndc (product): 0093-3093 ndc (product): 0093-3090 rxcui: 724863 rxcui: 724859 rxcui: 724861 rxcui: 861960 spl id: ca66f83d-4d17-4516-9163-abdb19872555 spl set id: b3cac300-c3d2-4189-a410-2aaf3773c090 unii: V63XWA605I
Armodafinil	ARMODAFINIL	Sandoz Inc	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	2023-01-31	Warnings, Adverse reactions	Exact identifier application number: NDA021875 ndc (package): 0781-8029-31 ndc (package): 0781-8037-31 ndc (package): 0781-8045-31 ndc (package): 0781-8053-31 ndc (product): 0781-8029 ndc (product): 0781-8045 ndc (product): 0781-8037 ndc (product): 0781-8053 rxcui: 724863 rxcui: 724859 rxcui: 724861 rxcui: 861960 spl id: dea0ad34-a35f-42ba-a6b6-dea58a16868f spl set id: a3341ec8-1ad4-49e2-922b-13d1b30c8c1d unii: V63XWA605I

Additional Listing Data#

Finished product: Yes
Brand name base: ARMODAFINIL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARMODAFINIL	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V63XWA605I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
724861	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf31ebd7-fd9d-472c-88e1-94944f023ec0	Product name	3	20190628

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-133-30	ARMODAFINIL	30 in 1 BOTTLE	TABLET	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-133	ARMODAFINIL TABLET [DIRECT RX]	4	Current NDC, Legacy NDC, 1 package rows	20250121_b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V63XWA605I	ARMODAFINIL	112111-43-0	ARMODAFINIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
724861	armodafinil 250 MG Oral Tablet	PSN	b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19	4
724861	armodafinil 250 MG Oral Tablet	SCD	b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-133-30	72189013330	30 TABLET in 1 BOTTLE (72189-133-30)	30 tablet	2020-10-15	0000-00-00	No	No	Current