National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 01:16:54

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
99207-271-75	GM - Gram	99207-271	1e2b033f-5268-4ac6-8d64-da3bacd2e84d	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
99207-271	99207-271-75

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
N022483-001	ZYCLARA	IMIQUIMOD	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25
N022483-002	ZYCLARA	IMIQUIMOD	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022483-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022483-001	10238645	2029-08-18	U-1455	2019-04-11
N022483-001	10238645	2029-08-18	U-172	2019-04-11
N022483-001	8598196	2029-08-18	U-1455	2013-12-11
N022483-001	8598196	2029-08-18	U-172	2013-12-11
N022483-001	10238644	2029-12-11	U-68	2019-04-11
N022483-001	8236816	2029-12-11	U-68	2012-08-08
N022483-001	8299109	2029-12-11	U-68	2012-11-01
N022483-001	10918635	2030-04-30	U-1455	2021-03-03
N022483-001	10918635	2030-04-30	U-172	2021-03-03
N022483-001	11202752	2030-04-30	U-1455	2022-01-19
N022483-001	11202752	2030-04-30	U-172	2022-01-19
N022483-001	11850245	2030-04-30	U-1455	2024-01-12
N022483-001	11850245	2030-04-30	U-172	2024-01-12
N022483-002	11318130	2029-12-11	U-68	2022-05-20
N022483-002	8222270	2029-12-11	U-68	2012-07-18

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 3 · 86 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
2026-09-14 22:38:34	2026-08	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL	AB	RLD, RS	2010-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022483-001	ZYCLARA	3.75%	CREAM / TOPICAL		RLD, RS	2010-03-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022483-002	ZYCLARA	2.5%	CREAM / TOPICAL		RLD, RS	2011-07-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022483-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022483-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022483-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022483-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022483-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022483-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022483-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022483-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022483-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022483-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022483-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022483-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022483-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022483-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022483-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022483-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022483-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022483-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022483-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022483-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022483-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022483-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022483-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022483-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022483-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022483-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022483-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022483-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022483-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022483-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022483-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022483-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022483-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022483-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022483-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022483-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022483-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 553 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022483-001	10238645	2029-08-18	U-172	2019-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-001	10238645	2029-08-18	U-1455	2019-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-001	8598196	2029-08-18	U-172	2013-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-001	8598196	2029-08-18	U-1455	2013-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-001	10238644	2029-12-11	U-68	2019-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-001	8236816	2029-12-11	U-68	2012-08-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-001	8299109	2029-12-11	U-68	2012-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-001	10918635	2030-04-30	U-172	2021-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-001	10918635	2030-04-30	U-1455	2021-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-001	11202752	2030-04-30	U-1455	2022-01-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-001	11202752	2030-04-30	U-172	2022-01-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-001	11850245	2030-04-30	U-1455	2024-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-001	11850245	2030-04-30	U-172	2024-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-002	11318130	2029-12-11	U-68	2022-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022483-002	8222270	2029-12-11	U-68	2012-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022483-001	10238645	2029-08-18	U-172	2019-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-001	10238645	2029-08-18	U-1455	2019-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-001	8598196	2029-08-18	U-172	2013-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-001	8598196	2029-08-18	U-1455	2013-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-001	10238644	2029-12-11	U-68	2019-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-001	8236816	2029-12-11	U-68	2012-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-001	8299109	2029-12-11	U-68	2012-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-001	10918635	2030-04-30	U-172	2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-001	10918635	2030-04-30	U-1455	2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-001	11202752	2030-04-30	U-1455	2022-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-001	11202752	2030-04-30	U-172	2022-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-001	11850245	2030-04-30	U-1455	2024-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-001	11850245	2030-04-30	U-172	2024-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-002	11318130	2029-12-11	U-68	2022-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022483-002	8222270	2029-12-11	U-68	2012-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10238645	2029-08-18	U-172	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10238645	2029-08-18	U-1455	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	8598196	2029-08-18	U-172	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	8598196	2029-08-18	U-1455	2013-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10238644	2029-12-11	U-68	2019-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	8236816	2029-12-11	U-68	2012-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	8299109	2029-12-11	U-68	2012-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10918635	2030-04-30	U-172	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	10918635	2030-04-30	U-1455	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022483-001	11202752	2030-04-30	U-1455	2022-01-19	`011fe1cb6892…`

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
Zyclara	IMIQUIMOD	Bausch Health US, LLC	28cd9b5b-680b-480f-b33d-9c5b52bbf03d	2025-05-23	Warnings, Adverse reactions	Exact identifier ndc (package): 99207-271-75 ndc11 (package): 99207027175

Reported adverse events (FAERS/openFDA)#

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