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 43.

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.

Product history page 1 of 2 · 43 observed 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
2026-09-14 22:38:34	2026-08	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017453-001	PROGLYCEM	50MG/ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N017453-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017453-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017453-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017453-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017453-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017453-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017453-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017453-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017453-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017453-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017453-001	AB	1	`d8e5a09893c0…`
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…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017453-001	AB	1	`a50c72e98297…`

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: 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

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
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

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