Pilocarpine Hydrochloride

Product NDC: 16714-121
11-digit product format: 167140121
Labeler code: 16714
Product ID: 16714-121_6eb119e3-f030-44d3-98d7-42d9fe0edbcc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pilocarpine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA212377
Marketing category: ANDA
Marketing start: 2019-08-13
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	16714-121		D	Discontinued by firm		2026-08-03
excluded package	package	16714-121	16714-121-01	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16714-121-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16714-121-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A212377-001	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-08-13
A212377-002	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2019-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212377-001	AB
A212377-002	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 2 · 80 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	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212377-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-08-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212377-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-08-13	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A212377-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212377-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212377-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212377-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212377-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212377-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212377-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212377-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212377-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212377-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212377-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212377-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212377-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212377-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212377-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212377-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212377-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212377-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212377-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212377-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212377-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212377-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212377-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212377-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212377-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212377-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212377-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212377-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212377-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212377-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212377-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212377-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212377-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212377-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212377-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212377-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212377-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212377-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212377-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212377-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-121-01	EA - Each	16714-121	84795939-62d8-4d89-b713-be5f3d23b835	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-121	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]	4	Legacy NDC	20240723_90c31478-4bd5-43bb-9287-d014b62c3b3f.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	Aurobindo Pharma Limited	438cfaa3-b5f6-4d75-ac22-b0b4e07bb118	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212377 application number: ANDA212377

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-121-01	16714012101	100 TABLET, FILM COATED in 1 BOTTLE (16714-121-01)	2019-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pilocarpine Hydrochloride Tablets, USP Rx only	NorthStar Rx LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2024-07-15	Human Prescription Drug Label	4