Proglycem

Product NDC: 0575-6200
11-digit product format: 005756200
Labeler code: 0575
Product ID: 0575-6200_451aa56d-e2e5-402f-843a-cddb5b3d37dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diazoxide
Dosage form: SUSPENSION
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: NDA017453
Marketing category: NDA
Marketing start: 1990-09-30
Substance: DIAZOXIDE
Active strength: 50 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017453-001	PROGLYCEM	DIAZOXIDE	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017453-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2024-10-29 15:01 UTC	2024-10	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL		RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL		RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL		RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL		RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, 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
2024-10-29 15:01 UTC	2024-10	N017453-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017453-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017453-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017453-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017453-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017453-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017453-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017453-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N017453-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017453-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017453-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017453-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017453-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017453-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017453-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017453-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017453-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017453-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017453-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017453-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017453-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017453-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017453-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017453-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017453-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017453-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017453-001	AB	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	N017453-001	AB	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Proglycem	DIAZOXIDE	Teva Pharmaceuticals USA, Inc.	b16c7832-2fd9-49af-b923-1dc0d91fd6e2	2024-07-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017453 application number: NDA017453 ndc (product): 0575-6200

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIAZOXIDE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O5CB12L4FN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197593	Internal RxNorm lookup
207634	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
b16c7832-2fd9-49af-b923-1dc0d91fd6e2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9a8e650a-7aae-491c-b4cb-53c9bf46f42d	Product name	1	20260112
dca952e2-dead-7d30-59c8-ab2d6e0c38a2	Product name	3	20210127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0575-6200-30	Proglycem	30 mL in 1 BOTTLE, DROPPER	SUSPENSION	30		15
0575-6200-30	Proglycem	1 in 1 BOX	SUSPENSION	1		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0575-6200-30	ML - Milliliter	0575-6200	fbc1bbbb-2ced-4c3c-8589-e9c0dd61a837	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIAZOXIDE	ACTIVE INGREDIENT	O5CB12L4FN	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
DIAZOXIDE	ACTIVE MOIETY	O5CB12L4FN	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	INACTIVE INGREDIENT	K679OBS311	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
SORBITOL	INACTIVE INGREDIENT	506T60A25R	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0575-6200	PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA PHARMACEUTICALS USA, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20240723_b16c7832-2fd9-49af-b923-1dc0d91fd6e2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O5CB12L4FN	DIAZOXIDE	364-98-7	DIAZOXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197593	diazoxide 50 MG in 1 mL Oral Suspension	PSN	b16c7832-2fd9-49af-b923-1dc0d91fd6e2	15
207634	Proglycem 50 MG in 1 mL Oral Suspension	PSN	b16c7832-2fd9-49af-b923-1dc0d91fd6e2	15
207634	diazoxide 50 MG/ML Oral Suspension [Proglycem]	SBD	b16c7832-2fd9-49af-b923-1dc0d91fd6e2	15
197593	diazoxide 50 MG/ML Oral Suspension	SCD	b16c7832-2fd9-49af-b923-1dc0d91fd6e2	15
197593	diazoxide 50 MG per 1 ML Oral Suspension	SY	b16c7832-2fd9-49af-b923-1dc0d91fd6e2	15
207634	Proglycem 50 MG per 1 ML Oral Suspension	SY	b16c7832-2fd9-49af-b923-1dc0d91fd6e2	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0575-6200-30	00575620030	1 BOTTLE, DROPPER in 1 BOX (0575-6200-30) / 30 mL in 1 BOTTLE, DROPPER	1990-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROGLYCEM ® (diazoxide) oral suspension	Teva Pharmaceuticals USA, Inc.	2024-07-19	HUMAN PRESCRIPTION DRUG LABEL	15