Strattera

Product NDC: 0002-3227
Requested package NDC: 0002-3227-30
11-digit product format: 000023227
Labeler code: 0002
Product ID: 0002-3227_8360d9e6-0df4-4969-9efa-7c01e69d6947
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atomoxetine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Eli Lilly and Company
Application: NDA021411
Marketing category: NDA
Marketing start: 2002-11-26
Marketing end: 2027-07-31
Substance: ATOMOXETINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag: No
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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021411-001	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		2002-11-26
N021411-002	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-003	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 18MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-004	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-005	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-006	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 60MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2002-11-26
N021411-007	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 80MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2005-02-14
N021411-008	STRATTERA	ATOMOXETINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2005-02-14

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 9 · 328 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	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL		RLD	2005-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL		RLD	2005-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL		RLD	2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL		RLD	2005-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL		RLD	2005-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-001	STRATTERA	EQ 5MG BASE	CAPSULE / ORAL			2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-002	STRATTERA	EQ 10MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-003	STRATTERA	EQ 18MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-004	STRATTERA	EQ 25MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-005	STRATTERA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-006	STRATTERA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-007	STRATTERA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-008	STRATTERA	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	2005-02-14	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 266 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N021411-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021411-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021411-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021411-008	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-007	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021411-008	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-006	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-007	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021411-008	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021411-006	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Strattera

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATOMOXETINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57WVB6I2W0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349591	Internal RxNorm lookup
349592	Internal RxNorm lookup
349593	Internal RxNorm lookup
349594	Internal RxNorm lookup
349595	Internal RxNorm lookup
352317	Internal RxNorm lookup
352318	Internal RxNorm lookup
352319	Internal RxNorm lookup
352320	Internal RxNorm lookup
352321	Internal RxNorm lookup
608139	Internal RxNorm lookup
608143	Internal RxNorm lookup
617945	Internal RxNorm lookup
617947	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
309de576-c318-404a-bc15-660c2b1876fb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0d16f546-db6a-1939-50fc-d06382424c97	Product name	4	20210903

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0002-3227-30	Strattera	30 in 1 BOTTLE	CAPSULE	30		66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-3227-30	EA - Each	0002-3227	1b88ecfe-b4cc-44f9-bf99-f46d9d10b72b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Atomoxetine hydrochloride	ACTIVE INGREDIENT	57WVB6I2W0	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]	54
Atomoxetine	ACTIVE MOIETY	ASW034S0B8	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]	54
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]	54
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]	54
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]	54
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]	54
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]	54
Gelatin	INACTIVE INGREDIENT	2G86QN327L	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]	54
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]	54
STARCH, Corn	INACTIVE INGREDIENT	O8232NY3SJ	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]	54
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE STRATTERA (ATOMOXETINE HYDROCHLORIDE) KIT [ELI LILLY AND COMPANY ]	54
Atomoxetine hydrochloride	ACTIVE INGREDIENT	57WVB6I2W0	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
Atomoxetine	ACTIVE MOIETY	ASW034S0B8	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-3227	STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [ELI LILLY AND COMPANY ]	65	Current NDC, Legacy NDC, 1 package rows	20241115_309de576-c318-404a-bc15-660c2b1876fb.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Strattera	ATOMOXETINE HYDROCHLORIDE	Eli Lilly and Company	309de576-c318-404a-bc15-660c2b1876fb	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021411 application number: NDA021411 ndc (package): 0002-3227-30 ndc (product): 0002-3227 ndc11 (package): 00002322730

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57WVB6I2W0	ATOMOXETINE HYDROCHLORIDE	82248-59-7	ATOMOXETINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349591	atomoxetine HCl 10 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
608139	atomoxetine HCl 100 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
349592	atomoxetine HCl 18 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
349593	atomoxetine HCl 25 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
349594	atomoxetine HCl 40 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
349595	atomoxetine HCl 60 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
608143	atomoxetine HCl 80 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
352317	Strattera 10 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
617945	Strattera 100 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
352318	Strattera 18 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
352319	Strattera 25 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
352320	Strattera 40 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
352321	Strattera 60 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
617947	Strattera 80 MG Oral Capsule	PSN	309de576-c318-404a-bc15-660c2b1876fb	66
352317	atomoxetine 10 MG Oral Capsule [Strattera]	SBD	309de576-c318-404a-bc15-660c2b1876fb	66
617945	atomoxetine 100 MG Oral Capsule [Strattera]	SBD	309de576-c318-404a-bc15-660c2b1876fb	66
352318	atomoxetine 18 MG Oral Capsule [Strattera]	SBD	309de576-c318-404a-bc15-660c2b1876fb	66
352319	atomoxetine 25 MG Oral Capsule [Strattera]	SBD	309de576-c318-404a-bc15-660c2b1876fb	66
352320	atomoxetine 40 MG Oral Capsule [Strattera]	SBD	309de576-c318-404a-bc15-660c2b1876fb	66
352321	atomoxetine 60 MG Oral Capsule [Strattera]	SBD	309de576-c318-404a-bc15-660c2b1876fb	66
617947	atomoxetine 80 MG Oral Capsule [Strattera]	SBD	309de576-c318-404a-bc15-660c2b1876fb	66
349591	atomoxetine 10 MG Oral Capsule	SCD	309de576-c318-404a-bc15-660c2b1876fb	66
608139	atomoxetine 100 MG Oral Capsule	SCD	309de576-c318-404a-bc15-660c2b1876fb	66
349592	atomoxetine 18 MG Oral Capsule	SCD	309de576-c318-404a-bc15-660c2b1876fb	66
349593	atomoxetine 25 MG Oral Capsule	SCD	309de576-c318-404a-bc15-660c2b1876fb	66
349594	atomoxetine 40 MG Oral Capsule	SCD	309de576-c318-404a-bc15-660c2b1876fb	66
349595	atomoxetine 60 MG Oral Capsule	SCD	309de576-c318-404a-bc15-660c2b1876fb	66
608143	atomoxetine 80 MG Oral Capsule	SCD	309de576-c318-404a-bc15-660c2b1876fb	66
349591	atomoxetine 10 MG (as atomoxetine hydrochloride) Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
608139	atomoxetine 100 MG (as atomoxetine HCl) Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
349592	atomoxetine 18 MG (as atomoxetine hydrochloride) Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
349593	atomoxetine 25 MG (as atomoxetine hydrochloride) Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
349594	atomoxetine 40 MG (as atomoxetine hydrochloride) Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
349595	atomoxetine 60 MG (as atomoxetine hydrochloride) Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
608143	atomoxetine 80 MG (as atomoxetine hydrochloride) Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
352317	Strattera 10 MG Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
617945	Strattera 100 MG Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
352318	Strattera 18 MG Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
352319	Strattera 25 MG Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
352320	Strattera 40 MG Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
352321	Strattera 60 MG Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
617947	Strattera 80 MG Oral Capsule	SY	309de576-c318-404a-bc15-660c2b1876fb	66
349591	atomoxetine HCl 10 MG Oral Capsule	PSN	6a7584b5-524d-4726-86a2-1b08e422f60e	2
352317	Strattera 10 MG Oral Capsule	PSN	6a7584b5-524d-4726-86a2-1b08e422f60e	2
352317	atomoxetine 10 MG Oral Capsule [Strattera]	SBD	6a7584b5-524d-4726-86a2-1b08e422f60e	2
349591	atomoxetine 10 MG Oral Capsule	SCD	6a7584b5-524d-4726-86a2-1b08e422f60e	2
349591	atomoxetine 10 MG (as atomoxetine hydrochloride) Oral Capsule	SY	6a7584b5-524d-4726-86a2-1b08e422f60e	2
352317	Strattera 10 MG Oral Capsule	SY	6a7584b5-524d-4726-86a2-1b08e422f60e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0002-3227-30	00002322730	30 CAPSULE in 1 BOTTLE (0002-3227-30)	30 capsule	2003-01-10	2027-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Strattera	Eli Lilly and Company	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	69
Strattera	Carilion Materials Management	2014-02-20	HUMAN PRESCRIPTION DRUG LABEL	2