Pilocarpine Hydrochloride

Product NDC: 50268-652
11-digit product format: 502680652
Labeler code: 50268
Product ID: 50268-652_47fb4499-fabd-6354-e063-6394a90a8c41
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pilocarpine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvPAK
Application: ANDA077220
Marketing category: ANDA
Marketing start: 2021-01-07
Substance: PILOCARPINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
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 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
A077220-001	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2005-10-14
A077220-002	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2009-05-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077220-001	AB
A077220-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077220-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077220-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077220-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077220-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077220-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077220-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077220-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077220-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077220-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077220-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077220-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077220-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077220-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077220-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077220-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077220-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077220-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077220-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077220-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077220-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077220-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077220-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077220-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077220-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077220-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077220-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077220-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077220-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077220-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077220-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077220-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077220-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077220-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077220-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077220-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077220-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077220-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077220-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077220-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077220-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PILOCARPINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0WW6D218XJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000913	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
b85547d8-fcec-323d-e053-2995a90a4e7e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
92fc48b4-3815-4611-a8be-f74b29f9b350	Product name	2	20260130
c8f45a17-34ae-46eb-871b-470615085910	Product name	1	20250630
dad00d81-2cbe-bbab-dd06-a12043b5e56d	Product name	4	20210512
419b812f-d1a6-2de2-5dee-bec68d6ec699	Product name	2	20200123
38c480e0-b6d3-b416-6514-a787406e5176	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-652-11	Pilocarpine Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		4
50268-652-12	Pilocarpine Hydrochloride	20 in 1 BOX	TABLET, FILM COATED	20		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-652-11	EA - Each	50268-652	27bd8cb7-14d7-4246-ab8f-42eb648a9737	1	2021-02-05
50268-652-12	EA - Each	50268-652	c06977fa-ad17-4d8c-ba29-56fb8eabbfc9	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-652	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AVPAK]	3	Current NDC, Legacy NDC, 2 package rows	20221116_b85547d8-fcec-323d-e053-2995a90a4e7e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	AvPAK	b85547d8-fcec-323d-e053-2995a90a4e7e	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220 ndc (product): 50268-652
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	06c054af-62b4-4373-813a-9bb2e5c92316	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	fb97323d-acec-4e4a-af16-efef66d969dc	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Lannett Company, Inc.	8db0db4f-55ad-46b2-af50-e71b4a763aaa	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	6a73a702-c5e2-44ea-81c8-ee7e60852c41	2024-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0WW6D218XJ	PILOCARPINE HYDROCHLORIDE	54-71-7	PILOCARPINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000913	pilocarpine HCl 5 MG Oral Tablet	PSN	b85547d8-fcec-323d-e053-2995a90a4e7e	4
1000913	pilocarpine hydrochloride 5 MG Oral Tablet	SCD	b85547d8-fcec-323d-e053-2995a90a4e7e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-652-11	50268065211	1 in 1 BLISTER PACK						Historical
50268-652-12	50268065212	20 BLISTER PACK in 1 BOX (50268-652-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-652-11)	20 blister pack	2021-01-07	0000-00-00	No	No	Current