Robinul Forte

Product NDC: 59630-205
11-digit product format: 596300205
Labeler code: 59630
Product ID: 59630-205_81777c49-9cf0-4835-b791-1b7776d70af9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate
Dosage form: TABLET
Route: ORAL
Labeler: Shionogi Inc.
Application: NDA012827
Marketing category: NDA
Marketing start: 1961-03-28
Marketing end: 0000-00-00
Substance: GLYCOPYRROLATE
Active strength: 2 mg/1
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	59630-205		D	Discontinued by firm		2026-07-31
excluded package	package	59630-205	59630-205-10	D	Discontinued by firm		2026-07-31

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
N012827-001	ROBINUL	GLYCOPYRROLATE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982
N012827-002	ROBINUL FORTE	GLYCOPYRROLATE	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N012827-001	AA
N012827-002	AA

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N012827-001	ROBINUL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N012827-002	ROBINUL FORTE	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N012827-001	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N012827-002	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	10ea264f-e157-4e13-9d79-b4228daf359d	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012827 application number: NDA012827
Glycopyrrolate	GLYCOPYRROLATE	Rising Pharma Holdings, Inc.	58c4cb1f-59b8-4be9-a222-2264ca077d93	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012827 application number: NDA012827

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59630-205-10	2019-12-12	C162847	48780-1	97449f38-d571-f6ea-e053-dbdaa90aa703	Robinul and Robinul Forte
59630-205-10	2019-11-13	C162847	48780-1	97449f38-d571-f6ea-e053-dbdaa90aa703	Robinul and Robinul Forte

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59630-205-10	EA - Each	59630-205	dab2e24e-90b2-4239-81ba-e167451f87f2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLYCOPYRROLATE	ACTIVE INGREDIENT	V92SO9WP2I	ROBINUL (GLYCOPYRROLATE) TABLET ROBINUL FORTE (GLYCOPYRROLATE) TABLET [SHIONOGI INC.]	7
GLYCOPYRRONIUM	ACTIVE MOIETY	A14FB57V1D	ROBINUL (GLYCOPYRROLATE) TABLET ROBINUL FORTE (GLYCOPYRROLATE) TABLET [SHIONOGI INC.]	7
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	ROBINUL (GLYCOPYRROLATE) TABLET ROBINUL FORTE (GLYCOPYRROLATE) TABLET [SHIONOGI INC.]	7
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ROBINUL (GLYCOPYRROLATE) TABLET ROBINUL FORTE (GLYCOPYRROLATE) TABLET [SHIONOGI INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ROBINUL (GLYCOPYRROLATE) TABLET ROBINUL FORTE (GLYCOPYRROLATE) TABLET [SHIONOGI INC.]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ROBINUL (GLYCOPYRROLATE) TABLET ROBINUL FORTE (GLYCOPYRROLATE) TABLET [SHIONOGI INC.]	7