pimecrolimus

Product NDC: 70518-2292
Requested package NDC: 70518-2292-0
11-digit product format: 705182292
Labeler code: 70518
Product ID: 70518-2292_e39cd6ec-d569-0daa-e053-2a95a90a28ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pimecrolimus
Dosage form: CREAM
Route: TOPICAL
Labeler: REMEDYREPACK INC.
Application: ANDA209345
Marketing category: ANDA
Marketing start: 2019-09-03
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	70518-2292	70518-2292-0	D	Discontinued by firm		2026-07-31

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
A209345-001	PIMECROLIMUS	PIMECROLIMUS	1%	CREAM / TOPICAL	AB		2018-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209345-001	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.

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
2026-08-01 22:54:32	2026-06	A209345-001	PIMECROLIMUS	1%	CREAM / TOPICAL	AB		2018-12-27	`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	A209345-001	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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pimecrolimus	PIMECROLIMUS	Actavis Pharma, Inc.	d5b0403a-065f-42e3-96d6-7dcb9ab127d3	2018-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209345 application number: ANDA209345

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
70518-2292-0	70518229200	30 g in 1 TUBE (70518-2292-0)	30 g	2019-09-03	0000-00-00	No	No	Current