Opill

Product NDC: 0113-8101
Requested package NDC: 0113-8101-01
11-digit product format: 001138101
Labeler code: 0113
Product ID: 0113-8101_fb2ad1e4-4e8a-4cee-a6e8-a823401dd8fe
Type: HUMAN OTC DRUG
Nonproprietary name: norgestrel
Dosage form: TABLET
Route: ORAL
Labeler: L. Perrigo Company
Application: NDA017031
Marketing category: NDA
Marketing start: 2024-03-04
Substance: NORGESTREL
Active strength: .075 mg/1
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 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
N017031-001	OPILL	NORGESTREL	0.075MG	TABLET / ORAL		RLD, RS, Approved before 1982

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N017031-001	RTO	2026-07-13

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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017031-001	OPILL	0.075MG	TABLET / ORAL	RLD, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017031-001	RTO	2026-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017031-001	RTO	2026-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017031-001	RTO	2026-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017031-001	RTO	2026-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017031-001	RTO	2026-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017031-001	RTO	2026-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017031-001	RTO	2026-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017031-001	RTO	2026-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017031-001	RTO	2026-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017031-001	RTO	2026-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017031-001	RTO	2026-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017031-001	RTO	2026-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017031-001	RTO	2026-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017031-001	RTO	2026-07-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017031-001	RTO	2026-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017031-001	RTO	2026-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017031-001	RTO	2026-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017031-001	RTO	2026-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017031-001	RTO	2026-07-13	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017031-001	RTO	2026-07-13	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NORGESTREL	.075 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3J8Q1747Z2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
203717	Internal RxNorm lookup
762335	Internal RxNorm lookup
2676107	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
69dfa2ac-6a7e-4587-929c-9acabd97973b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d9a998ac-31a9-4391-9054-c30e50912603	Product name	2	20240829
2d386545-84d1-e1e9-1402-7fc8962353e8	Product name	2	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0113-8101-01	Opill	28 in 1 BLISTER PACK	TABLET	28	4
0113-8101-01	Opill	1 in 1 CARTON	TABLET	1	4
0113-8101-03	Opill	3 in 1 CARTON	TABLET	3	4
0113-8101-03	Opill	28 in 1 BLISTER PACK	TABLET	28	4
0113-8101-04	Opill	4 in 1 PACKAGE	TABLET	4	4
0113-8101-04	Opill	28 in 1 BLISTER PACK	TABLET	28	4
0113-8101-06	Opill	28 in 1 BLISTER PACK	TABLET	28	4
0113-8101-06	Opill	6 in 1 CARTON	TABLET	6	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0113-8101-01	EA - Each	0113-8101	94ea3eea-61bf-4b8c-84d6-66a71c96b486	1	2024-04-05
0113-8101-03	EA - Each	0113-8101	3d1324b8-998a-49a1-9672-5c67787fce4e	1	2024-04-05
0113-8101-04	EA - Each	0113-8101	657db9a4-6048-4c63-b75d-b8edec0833be	1	2024-06-10
0113-8101-06	EA - Each	0113-8101	5eb27d4e-548d-4bfd-8acd-10d24acc235a	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0113-8101	OPILL (NORGESTREL) TABLET [L. PERRIGO COMPANY]	4	Current NDC, 8 package rows	20250129_69dfa2ac-6a7e-4587-929c-9acabd97973b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NORGESTREL	NORGESTREL	Walgreen Company	4d882142-e253-42d3-87b2-a4f92ce82162	2026-07-09	Warnings	Exact identifier application applno (NDA): 017031 application number: NDA017031
Opill	NORGESTREL	Redpharm Drug	303264da-c919-e0ce-e063-6394a90a4cc7	2025-12-25	Warnings	Exact identifier application applno (NDA): 017031 application number: NDA017031
Opill	NORGESTREL	L. Perrigo Company	69dfa2ac-6a7e-4587-929c-9acabd97973b	2025-01-27	Warnings	Exact identifier application applno (NDA): 017031 application number: NDA017031 ndc (package): 0113-8101-01 ndc (product): 0113-8101 ndc11 (package): 00113810101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3J8Q1747Z2	NORGESTREL	6533-00-2	NORGESTREL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2676107	{28 (norgestrel 0.075 MG Oral Tablet) } Pack [Opill 28 Day]	BPCK	69dfa2ac-6a7e-4587-929c-9acabd97973b	4
762335	{28 (norgestrel 0.075 MG Oral Tablet) } Pack	GPCK	69dfa2ac-6a7e-4587-929c-9acabd97973b	4
203717	norgestrel 75 MCG Oral Tablet	PSN	69dfa2ac-6a7e-4587-929c-9acabd97973b	4
2676107	Opill 28 Day Pack	PSN	69dfa2ac-6a7e-4587-929c-9acabd97973b	4
203717	norgestrel 0.075 MG Oral Tablet	SCD	69dfa2ac-6a7e-4587-929c-9acabd97973b	4
762335	Norgestrel 0.075 MG Oral Tablet 28 Count Pack	SY	69dfa2ac-6a7e-4587-929c-9acabd97973b	4
2676107	Opill 28 Day Pack	SY	69dfa2ac-6a7e-4587-929c-9acabd97973b	4
2676107	{28 (norgestrel 0.075 MG Oral Tablet) } Pack [Opill 28 Day]	BPCK	303264da-c919-e0ce-e063-6394a90a4cc7	3
762335	{28 (norgestrel 0.075 MG Oral Tablet) } Pack	GPCK	303264da-c919-e0ce-e063-6394a90a4cc7	3
203717	norgestrel 75 MCG Oral Tablet	PSN	303264da-c919-e0ce-e063-6394a90a4cc7	3
2676107	Opill 28 Day Pack	PSN	303264da-c919-e0ce-e063-6394a90a4cc7	3
203717	norgestrel 0.075 MG Oral Tablet	SCD	303264da-c919-e0ce-e063-6394a90a4cc7	3
762335	Norgestrel 0.075 MG Oral Tablet 28 Count Pack	SY	303264da-c919-e0ce-e063-6394a90a4cc7	3
2676107	Opill 28 Day Pack	SY	303264da-c919-e0ce-e063-6394a90a4cc7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0113-8101-01	00113810101	1 BLISTER PACK in 1 CARTON (0113-8101-01) / 28 TABLET in 1 BLISTER PACK	1 blister pack	2024-03-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Opill ® Norgestrel tablets 0.075 mg - Drug Facts	Redpharm Drug	2025-12-25	HUMAN OTC DRUG LABEL	3
Opill ® Norgestrel tablets 0.075 mg - Drug Facts	L. Perrigo Company	2025-01-27	HUMAN OTC DRUG LABEL	4