Penciclovir

Product NDC: 13668-661
11-digit product format: 136680661
Labeler code: 13668
Product ID: 13668-661_05e9763e-c5f9-4be9-b822-8242a44e76ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: penciclovir
Dosage form: CREAM
Route: TOPICAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA216981
Marketing category: ANDA
Marketing start: 2023-08-07
Substance: PENCICLOVIR
Active strength: 10 mg/g
Pharmacologic classes: DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A216981-001	PENCICLOVIR	PENCICLOVIR	1%	CREAM / TOPICAL	BX		2023-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216981-001	BX

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	BX	2023-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	BX	2023-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	BX	2023-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	BX	2023-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	AB	2023-08-07	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216981-001	PENCICLOVIR	1%	CREAM / TOPICAL	BX	2023-08-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216981-001	BX	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216981-001	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216981-001	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216981-001	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216981-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216981-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216981-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216981-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216981-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216981-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216981-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216981-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216981-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216981-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216981-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216981-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216981-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216981-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216981-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216981-001	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216981-001	BX	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216981-001	CGT	2024-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216981-001	CGT	2024-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216981-001	CGT	2024-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216981-001	CGT	2024-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216981-001	CGT	2024-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216981-001	CGT	2024-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216981-001	CGT	2024-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216981-001	CGT	2024-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216981-001	CGT	2024-02-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216981-001	CGT	2024-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216981-001	CGT	2024-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216981-001	CGT	2024-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216981-001	CGT	2024-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216981-001	CGT	2024-02-28	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: Penciclovir
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PENCICLOVIR	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
359HUE8FJC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312255	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
dfbd90ed-4135-486a-807b-27c668154b2e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1005b6ff-d0c1-48ab-8c99-f6ab62104661	Product name	2	20250401
39b4c6c3-4107-094f-96fa-0d1c48033493	Product name	2	20150326

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13668-661-10	Penciclovir	1 in 1 CARTON	CREAM	1		7
13668-661-10	Penciclovir	5 g in 1 TUBE	CREAM	5		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-661-10	GM - Gram	13668-661	07663816-e12b-4c34-8425-16d1b28ee9db	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-661	PENCICLOVIR CREAM [TORRENT PHARMACEUTICALS LIMITED]	6	Current NDC, 2 package rows	20250206_dfbd90ed-4135-486a-807b-27c668154b2e.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
Penciclovir	PENCICLOVIR	Torrent Pharmaceuticals Limited	dfbd90ed-4135-486a-807b-27c668154b2e	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216981 application number: ANDA216981 ndc (product): 13668-661

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
359HUE8FJC	PENCICLOVIR	39809-25-1	PENCICLOVIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312255	penciclovir 1 % Topical Cream	PSN	dfbd90ed-4135-486a-807b-27c668154b2e	7
312255	penciclovir 10 MG/ML Topical Cream	SCD	dfbd90ed-4135-486a-807b-27c668154b2e	7
312255	penciclovir 1 % Topical Cream	SY	dfbd90ed-4135-486a-807b-27c668154b2e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
13668-661-10	13668066110	1 TUBE in 1 CARTON (13668-661-10) / 5 g in 1 TUBE	1 tube	2023-08-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Penciclovir	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	7