Pilocarpine Hydrochloride

Product NDC: 70069-201
11-digit product format: 700690201
Labeler code: 70069
Product ID: 70069-201_82a2d0b0-5ac5-46a1-b945-1f5669cc75ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pilocarpine Hydrochloride Ophthalmic Solution
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Somerset Therapeutics, LLC
Application: ANDA210384
Marketing category: ANDA
Marketing start: 2019-11-25
Substance: PILOCARPINE HYDROCHLORIDE
Active strength: 40 mg/mL
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210384-001	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25
A210384-002	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25
A210384-003	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A210384-001	AT
A210384-002	AT
A210384-003	AT

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 · 114 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	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2019-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210384-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210384-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210384-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2019-11-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A210384-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210384-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210384-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210384-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210384-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210384-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210384-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210384-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210384-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210384-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210384-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210384-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210384-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210384-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210384-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210384-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210384-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210384-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210384-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210384-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210384-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210384-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210384-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210384-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210384-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210384-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210384-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210384-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210384-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210384-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210384-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210384-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210384-003	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210384-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210384-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210384-003	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210384-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210384-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210384-003	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210384-001	AT	1	`8072bd15b7f6…`

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	40 mg/mL

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000647	Internal RxNorm lookup
1000862	Internal RxNorm lookup
1000897	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
84428e9a-f486-44d9-ad93-4ea9069a6787	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
70069-201-01	Pilocarpine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		8
70069-201-01	Pilocarpine Hydrochloride	15 mL in 1 BOTTLE	SOLUTION/ DROPS	15		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70069-201-01	ML - Milliliter	70069-201	06dc75d1-fa5a-4609-b22c-c6ba6630bd6a	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70069-201	PILOCARPINE HYDROCHLORIDE (PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION) SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20230602_84428e9a-f486-44d9-ad93-4ea9069a6787.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
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION	Somerset Therapeutics, LLC	84428e9a-f486-44d9-ad93-4ea9069a6787	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210384 application number: ANDA210384 ndc (product): 70069-201

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
1000647	pilocarpine HCl 1 % Ophthalmic Solution	PSN	84428e9a-f486-44d9-ad93-4ea9069a6787	8
1000862	pilocarpine HCl 2 % Ophthalmic Solution	PSN	84428e9a-f486-44d9-ad93-4ea9069a6787	8
1000897	pilocarpine HCl 4 % Ophthalmic Solution	PSN	84428e9a-f486-44d9-ad93-4ea9069a6787	8
1000647	pilocarpine hydrochloride 10 MG/ML Ophthalmic Solution	SCD	84428e9a-f486-44d9-ad93-4ea9069a6787	8
1000862	pilocarpine hydrochloride 20 MG/ML Ophthalmic Solution	SCD	84428e9a-f486-44d9-ad93-4ea9069a6787	8
1000897	pilocarpine hydrochloride 40 MG/ML Ophthalmic Solution	SCD	84428e9a-f486-44d9-ad93-4ea9069a6787	8
1000647	pilocarpine hydrochloride 1 % Ophthalmic Solution	SY	84428e9a-f486-44d9-ad93-4ea9069a6787	8
1000862	pilocarpine hydrochloride 2 % Ophthalmic Solution	SY	84428e9a-f486-44d9-ad93-4ea9069a6787	8
1000897	pilocarpine hydrochloride 4 % Ophthalmic Solution	SY	84428e9a-f486-44d9-ad93-4ea9069a6787	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70069-201-01	70069020101	1 BOTTLE in 1 CARTON (70069-201-01) / 15 mL in 1 BOTTLE	1 bottle	2019-11-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pilocarpine Hydrochloride Ophthalmic Solution	Somerset Therapeutics, LLC \| Somerset Therapeutics Private Limited	2025-12-22	HUMAN PRESCRIPTION DRUG LABEL	8