Spironolactone and Hydrochlorothiazide

Product NDC: 66993-188
11-digit product format: 669930188
Labeler code: 66993
Product ID: 66993-188_eca75090-9808-4673-bd7e-1ecd571d3b3e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone and hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Prasco Laboratories
Application: NDA012616
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2021-11-29
Substance: HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
Active strength: 25; 25 mg/1; mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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 42.

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
N012616-004	ALDACTAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30
N012616-005	ALDACTAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N012616-004	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 3 · 84 observed 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
2026-08-18 06:07:40	2026-07	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD, RS	1982-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD, RS	1982-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD, RS	1982-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD, RS	1982-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD, RS	1982-12-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N012616-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012616-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012616-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012616-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012616-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012616-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012616-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012616-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012616-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012616-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012616-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012616-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012616-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012616-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012616-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012616-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012616-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012616-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012616-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012616-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012616-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012616-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012616-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012616-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012616-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012616-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012616-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012616-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012616-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012616-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012616-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012616-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012616-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012616-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012616-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012616-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012616-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012616-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012616-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012616-004	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Spironolactone and Hydrochlorothiazide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SPIRONOLACTONE	25 mg/1
HYDROCHLOROTHIAZIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
27O7W4T232	Internal UNII lookup
0J48LPH2TH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198224	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
9d350fa2-d568-4970-a7a5-d128ff5d0a2f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
d335cba1-5b36-51c8-120a-594ec9d05330	Product name	5	20251114
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
25f5e2cf-3572-477b-994c-aa692751e5a8	Product name	2	20250616
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66993-188-02	Spironolactone and Hydrochlorothiazide	100 in 1 BOTTLE	TABLET, FILM COATED	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-188-02	EA - Each	66993-188	28a9ccb2-7129-45c9-81c2-9e6e13a9b402	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-188	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PRASCO LABORATORIES]	7	Current NDC, Legacy NDC, 1 package rows	20250123_9d350fa2-d568-4970-a7a5-d128ff5d0a2f.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
Spironolactone and Hydrochlorothiazide	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	Prasco Laboratories	9d350fa2-d568-4970-a7a5-d128ff5d0a2f	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012616 application number: NDA012616 ndc (product): 66993-188

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
27O7W4T232	SPIRONOLACTONE	52-01-7	SPIRONOLACTONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198224	spironolactone 25 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	9d350fa2-d568-4970-a7a5-d128ff5d0a2f	8
198224	hydrochlorothiazide 25 MG / spironolactone 25 MG Oral Tablet	SCD	9d350fa2-d568-4970-a7a5-d128ff5d0a2f	8
198224	HCTZ 25 MG / spironolactone 25 MG Oral Tablet	SY	9d350fa2-d568-4970-a7a5-d128ff5d0a2f	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-188-02	66993018802	100 TABLET, FILM COATED in 1 BOTTLE (66993-188-02)	2021-11-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spironolactone and Hydrochlorothiazide Tablets	Prasco Laboratories \| Pfizer Manufacturing Deutschland GmbH	2026-02-10	HUMAN PRESCRIPTION DRUG LABEL	8