Tacrolimus

Product NDC: 16729-421
11-digit product format: 167290421
Labeler code: 16729
Product ID: 16729-421_23a804e6-2854-6b9b-e063-6394a90af669
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Accord Healthcare Inc.
Application: ANDA211688
Marketing category: ANDA
Marketing start: 2019-05-31
Substance: TACROLIMUS
Active strength: .3 mg/g
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 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
A211688-001	TACROLIMUS	TACROLIMUS	0.03%	OINTMENT / TOPICAL	AB		2019-01-31
A211688-002	TACROLIMUS	TACROLIMUS	0.1%	OINTMENT / TOPICAL	AB		2019-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211688-001	AB
A211688-002	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 3 of 3 · 86 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
2022-09-29 23:25 UTC	2022-09	A211688-001	TACROLIMUS	0.03%	OINTMENT / TOPICAL	AB	2019-01-31	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A211688-002	TACROLIMUS	0.1%	OINTMENT / TOPICAL	AB	2019-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211688-001	TACROLIMUS	0.03%	OINTMENT / TOPICAL	AB	2019-01-31	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211688-002	TACROLIMUS	0.1%	OINTMENT / TOPICAL	AB	2019-01-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211688-001	TACROLIMUS	0.03%	OINTMENT / TOPICAL	AB	2019-01-31	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211688-002	TACROLIMUS	0.1%	OINTMENT / TOPICAL	AB	2019-01-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211688-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211688-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211688-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211688-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211688-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211688-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211688-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211688-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211688-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211688-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211688-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211688-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211688-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211688-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211688-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211688-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211688-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211688-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211688-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211688-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211688-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211688-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211688-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211688-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211688-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211688-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211688-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211688-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211688-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211688-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211688-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211688-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211688-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211688-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211688-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211688-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211688-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211688-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211688-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211688-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TACROLIMUS	.3 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313189	Internal RxNorm lookup
314266	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
80e6817a-9b1e-4f0f-e053-2a91aa0a3d15	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	SPL version
16729-421-01	Tacrolimus	100 g in 1 TUBE	OINTMENT	100	5
16729-421-01	Tacrolimus	1 in 1 CARTON	OINTMENT	1	5
16729-421-10	Tacrolimus	30 g in 1 TUBE	OINTMENT	30	5
16729-421-10	Tacrolimus	1 in 1 CARTON	OINTMENT	1	5
16729-421-12	Tacrolimus	60 g in 1 TUBE	OINTMENT	60	5
16729-421-12	Tacrolimus	1 in 1 CARTON	OINTMENT	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-421-01	GM - Gram	16729-421	ab7fdd17-722b-458f-a889-974b0703db73	1	2019-06-19
16729-421-10	GM - Gram	16729-421	7c915788-9d20-4575-ba80-b0b9b265ed3f	1	2019-06-19
16729-421-12	GM - Gram	16729-421	91039515-02d4-4df3-b61c-ca0f32881f09	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-421	TACROLIMUS OINTMENT [ACCORD HEALTHCARE INC.]	5	Current NDC, Legacy NDC, 6 package rows	20241006_80e6817a-9b1e-4f0f-e053-2a91aa0a3d15.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
Tacrolimus	TACROLIMUS	Accord Healthcare Inc.	80e6817a-9b1e-4f0f-e053-2a91aa0a3d15	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211688 application number: ANDA211688 ndc (product): 16729-421

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
313189	tacrolimus 0.03 % Topical Ointment	PSN	80e6817a-9b1e-4f0f-e053-2a91aa0a3d15	5
314266	tacrolimus 0.1 % Topical Ointment	PSN	80e6817a-9b1e-4f0f-e053-2a91aa0a3d15	5
313189	tacrolimus 0.0003 MG/MG Topical Ointment	SCD	80e6817a-9b1e-4f0f-e053-2a91aa0a3d15	5
314266	tacrolimus 0.001 MG/MG Topical Ointment	SCD	80e6817a-9b1e-4f0f-e053-2a91aa0a3d15	5
313189	tacrolimus (as tacrolimus monohydrate) 0.0003 MG/MG Topical Ointment	SY	80e6817a-9b1e-4f0f-e053-2a91aa0a3d15	5
314266	tacrolimus (as tacrolimus monohydrate) 0.001 MG/MG Topical Ointment	SY	80e6817a-9b1e-4f0f-e053-2a91aa0a3d15	5
313189	tacrolimus 0.03 % Topical Ointment	SY	80e6817a-9b1e-4f0f-e053-2a91aa0a3d15	5
314266	tacrolimus 0.1 % Topical Ointment	SY	80e6817a-9b1e-4f0f-e053-2a91aa0a3d15	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-421-01	16729042101	1 TUBE in 1 CARTON (16729-421-01) / 100 g in 1 TUBE	1 tube	2019-06-05	0000-00-00	No	No	Current
16729-421-10	16729042110	1 TUBE in 1 CARTON (16729-421-10) / 30 g in 1 TUBE	1 tube	2019-05-31	0000-00-00	No	No	Current
16729-421-12	16729042112	1 TUBE in 1 CARTON (16729-421-12) / 60 g in 1 TUBE	1 tube	2019-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tacrolimus Ointment, 0.03% and 0.1% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2024-10-04	HUMAN PRESCRIPTION DRUG LABEL	5