Tacrolimus

Product NDC: 82009-164
Requested package NDC: 82009-164-01
11-digit product format: 820090164
Labeler code: 82009
Product ID: 82009-164_3e44dd25-4ad2-6ddc-f77b-7a66fc7fb89a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE
Route: ORAL
Labeler: Quallent Pharmaceuticals Health LLC
Application: ANDA090509
Marketing category: ANDA
Marketing start: 2025-06-01
Substance: TACROLIMUS
Active strength: .5 mg/1
Pharmacologic classes: Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090509-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12
A090509-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12
A090509-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090509-001	AB
A090509-002	AB
A090509-003	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.

Product history page 1 of 4 · 123 observed 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
2026-02-19 14:30 UTC	2026-02	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090509-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090509-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090509-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-05-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090509-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090509-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090509-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090509-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090509-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090509-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090509-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090509-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090509-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090509-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090509-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090509-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090509-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090509-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090509-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090509-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090509-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090509-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090509-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090509-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090509-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090509-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TACROLIMUS	.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WM0HAQ4WNM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198377	Internal RxNorm lookup
198378	Internal RxNorm lookup
313190	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
23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
df369ad4-19d8-393a-de46-8c6255b8b360	Product name	8	20251120
d2a74186-7b26-dbcc-9435-50b3d0be14ab	Product name	2	20250114
a64835ae-fa9d-41d8-9a93-36828ba72b96	Product name	3	20190611
b4a869e4-9fcd-47bd-95e3-85e7c75f8bad	Product name	1	20150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82009-164-01	Tacrolimus	100 in 1 BOTTLE	CAPSULE	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82009-164-01	EA - Each	82009-164	c507546b-81bf-4c51-809a-e7478c05315b	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82009-164	TACROLIMUS CAPSULE [QUALLENT PHARMACEUTICALS HEALTH LLC]	3	Current NDC, 1 package rows	20250402_23b7b4d7-1431-e9f2-43ba-eabd169dc2dd.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Major Pharmaceuticals	0addf3f5-9bd5-4ef3-8c7f-52be20c16cf9	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090509 application number: ANDA090509
Tacrolimus	TACROLIMUS	Quallent Pharmaceuticals Health LLC	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090509 application number: ANDA090509 ndc (package): 82009-164-01 ndc (product): 82009-164 ndc11 (package): 82009016401
Tacrolimus	TACROLIMUS	American Health Packaging	93d03943-0655-44f6-b494-57bd1e336a34	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090509 application number: ANDA090509
Tacrolimus	TACROLIMUS	Dr. Reddy's Laboratories Limited	61dee012-43af-0e9a-3843-9b9b91e022c4	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090509 application number: ANDA090509

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WM0HAQ4WNM	TACROLIMUS	109581-93-3	TACROLIMUS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313190	tacrolimus 0.5 MG Oral Capsule	PSN	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	4
198377	tacrolimus 1 MG Oral Capsule	PSN	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	4
198378	tacrolimus 5 MG Oral Capsule	PSN	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	4
313190	tacrolimus 0.5 MG Oral Capsule	SCD	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	4
198377	tacrolimus 1 MG Oral Capsule	SCD	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	4
198378	tacrolimus 5 MG Oral Capsule	SCD	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	4
313190	tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral Capsule	SY	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	4
198377	tacrolimus 1 MG (as anhydrous tacrolimus) Oral Capsule	SY	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	4
198378	tacrolimus 5 MG (as anhydrous tacrolimus) Oral Capsule	SY	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82009-164-01	82009016401	100 CAPSULE in 1 BOTTLE (82009-164-01)	100 capsule	2025-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tacrolimus	Quallent Pharmaceuticals Health LLC \| Dr. Reddy's Laboratories Limited - FTO3	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL	4