Misoprostol

Product NDC: 43393-023
11-digit product format: 433930023
Labeler code: 43393
Product ID: 43393-023_f19b951f-2e45-7072-e053-2a95a90ac730
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Misoprostol
Dosage form: TABLET
Route: ORAL
Labeler: GenBioPro, Inc.
Application: ANDA076095
Marketing category: ANDA
Marketing start: 2023-01-01
Substance: MISOPROSTOL
Active strength: 200 ug/1
Pharmacologic classes: Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076095-001	MISOPROSTOL	MISOPROSTOL	0.1MG	TABLET / ORAL	AB		2002-07-10
A076095-002	MISOPROSTOL	MISOPROSTOL	0.2MG	TABLET / ORAL	AB		2002-07-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076095-001	AB
A076095-002	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 3 · 82 observed 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
2026-02-19 14:30 UTC	2026-02	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2002-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2002-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2002-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2002-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2002-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2002-07-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A076095-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076095-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076095-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076095-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076095-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076095-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076095-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076095-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076095-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076095-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076095-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076095-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076095-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076095-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076095-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076095-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076095-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076095-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076095-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076095-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076095-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076095-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076095-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076095-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076095-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076095-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076095-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076095-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076095-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076095-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076095-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076095-002	AB	1	`5d02ea3f76ae…`
2019-12-13 00:20 UTC	2019-12	A076095-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076095-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076095-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076095-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076095-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076095-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076095-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076095-002	AB	1	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MISOPROSTOL	200 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0E43V0BB57	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
317128	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
2f4d6f06-529c-4b54-908a-0db4c18aff67	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
73109aa8-3e7c-b7a0-fb29-6f84db91e7d9	Product name	3	20231221
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43393-023-04	Misoprostol	4 in 1 BOTTLE	TABLET	4		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43393-023-04	EA - Each	43393-023	6d9ba983-78bd-4650-8e87-a156a026c81b	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43393-023	MISOPROSTOL TABLET [GENBIOPRO, INC.]	1	Current NDC, Legacy NDC, 1 package rows	20230111_2f4d6f06-529c-4b54-908a-0db4c18aff67.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Misoprostol	MISOPROSTOL	American Health Packaging	9462d969-d3e5-4e7f-b556-bd647ab28c42	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	Bryant Ranch Prepack	c4668066-3d67-487d-9071-f1e504f66499	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	51b0bac5-19e3-4547-ba1f-01494fda7687	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	Cardinal Health 107, LLC	52a82e45-afc5-47d0-a77f-a225609e2f6b	2025-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	ANI Pharmaceuticals, Inc.	21386aa1-dc51-41c9-8872-dec4c71ebb46	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	NuCare Pharmaceuticals, Inc.	2b5d0fcb-cc9c-5bb0-e063-6294a90ab1c8	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	Proficient Rx LP	85410e16-d164-4666-9539-778e2b4dd138	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	GenBioPro, Inc.	2f4d6f06-529c-4b54-908a-0db4c18aff67	2023-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095 ndc (product): 43393-023

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0E43V0BB57	MISOPROSTOL	59122-46-2	MISOPROSTOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
317128	miSOPROStol 200 MCG Oral Tablet	PSN	2f4d6f06-529c-4b54-908a-0db4c18aff67	1
317128	misoprostol 0.2 MG Oral Tablet	SCD	2f4d6f06-529c-4b54-908a-0db4c18aff67	1
317128	misoprostol 200 MCG Oral Tablet	SY	2f4d6f06-529c-4b54-908a-0db4c18aff67	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43393-023-04	43393002304	4 TABLET in 1 BOTTLE (43393-023-04)	4 tablet	2023-01-01	0000-00-00	No	No	Current