ELIDEL

Product NDC: 0187-5102
Requested package NDC: 0187-5102-03
11-digit product format: 001875102
Labeler code: 0187
Product ID: 0187-5102_2f802a3f-c021-45c1-8693-5689c30c3fc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pimecrolimus
Dosage form: CREAM
Route: TOPICAL
Labeler: Bausch Health US, LLC
Application: NDA021302
Marketing category: NDA
Marketing start: 2001-12-02
Marketing end: 0000-00-00
Substance: PIMECROLIMUS
Active strength: 10 mg/g
Pharmacologic classes: Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	0187-5102	0187-5102-03	D	Discontinued by firm		2026-08-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021302-001	ELIDEL	PIMECROLIMUS	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021302-001	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 2 · 41 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	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N021302-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021302-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021302-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021302-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021302-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021302-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021302-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021302-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021302-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021302-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021302-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021302-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021302-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021302-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021302-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021302-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021302-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021302-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021302-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021302-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021302-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021302-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021302-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021302-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021302-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021302-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021302-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021302-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021302-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021302-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021302-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021302-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021302-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021302-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021302-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021302-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021302-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021302-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021302-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021302-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-5102-03	GM - Gram	0187-5102	68a05a59-c085-4205-846a-d1157db2c8a5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Pimecrolimus	ACTIVE INGREDIENT	7KYV510875	ELIDEL (PIMECROLIMUS) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
Pimecrolimus	ACTIVE MOIETY	7KYV510875	ELIDEL (PIMECROLIMUS) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ELIDEL (PIMECROLIMUS) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	ELIDEL (PIMECROLIMUS) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ELIDEL (PIMECROLIMUS) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	ELIDEL (PIMECROLIMUS) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
OLEYL ALCOHOL	INACTIVE INGREDIENT	172F2WN8DV	ELIDEL (PIMECROLIMUS) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ELIDEL (PIMECROLIMUS) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
SODIUM CETOSTEARYL SULFATE	INACTIVE INGREDIENT	7ZBS06BH4B	ELIDEL (PIMECROLIMUS) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ELIDEL (PIMECROLIMUS) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	ELIDEL (PIMECROLIMUS) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	ELIDEL (PIMECROLIMUS) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-5102	ELIDEL (PIMECROLIMUS) CREAM [BAUSCH HEALTH US, LLC]	15	Legacy NDC	20201215_e4027e5a-0f9b-4070-b196-f60172f45c4c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pimecrolimus	PIMECROLIMUS	Oceanside Pharmaceuticals	6601e43e-ce7d-446a-8568-8e7b24b86f06	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021302 application number: NDA021302
Pimecrolimus	PIMECROLIMUS	Bryant Ranch Prepack	dc8708ec-16be-4c27-8a5e-bf84723408fe	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021302 application number: NDA021302

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7KYV510875	PIMECROLIMUS	137071-32-0	PIMECROLIMUS

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-5102-03	00187510203	1 TUBE in 1 CARTON (0187-5102-03) > 100 g in 1 TUBE	1 tube	2001-12-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ELIDEL	Bausch Health US, LLC \| Novartis Pharma GmbH \| Bausch Health Companies Inc.	2020-09-30	HUMAN PRESCRIPTION DRUG LABEL	15