PROMETHEGAN

Product NDC: 0713-0536
11-digit product format: 007130536
Labeler code: 0713
Product ID: 0713-0536_0b622b7b-a45f-eab0-e063-6394a90a0c0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: promethazine hydrochloride
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Cosette Pharmaceuticals, Inc.
Application: ANDA040428
Marketing category: ANDA
Marketing start: 2004-02-28
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 12.5 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040428-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05
A040428-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040428-001	AB
A040428-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040428-001	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	RS	2002-02-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040428-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-03-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A040428-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040428-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040428-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040428-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040428-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040428-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040428-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040428-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040428-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040428-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040428-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040428-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040428-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040428-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040428-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040428-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040428-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040428-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040428-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040428-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040428-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040428-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040428-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040428-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040428-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040428-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040428-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040428-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040428-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040428-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040428-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040428-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040428-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040428-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040428-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040428-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040428-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040428-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040428-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040428-002	AB	1	`782e0a99824c…`

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
PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97	2025-10-20	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 040428 application number: ANDA040428
PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	5f079815-f48b-8b21-2130-7f791d967c9a	2023-11-30	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 040428 application number: ANDA040428 ndc (product): 0713-0536

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R61ZEH7I1I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992441	Internal RxNorm lookup
992445	Internal RxNorm lookup
992454	Internal RxNorm lookup
992459	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
5f079815-f48b-8b21-2130-7f791d967c9a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3036445d-7d13-4411-a100-f2ac5ab8a276	Product name	1	20240110
2e7222fb-e3f1-febd-962f-ddbb495d6b5f	Product name	2	20220126
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
4f881de7-085a-407e-abc2-faa3c0127432	Product name	1	20170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
d51697af-7f97-0559-95d1-fe94f3f031d5	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0713-0536-10	PROMETHEGAN	1000 in 1 BOX	SUPPOSITORY	1000		7
0713-0536-12	PROMETHEGAN	12 in 1 BOX	SUPPOSITORY	12		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0713-0536-12	EA - Each	0713-0536	187ba0d9-3a0f-4b4e-a7bb-2d3088abf131	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Promethazine Hydrochloride	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]	2
Promethazine	ACTIVE MOIETY	FF28EJQ494	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]	2
Ascorbyl Palmitate	INACTIVE INGREDIENT	QN83US2B0N	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]	2
Fat, Hard	INACTIVE INGREDIENT	8334LX7S21	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]	2
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]	2
White Wax	INACTIVE INGREDIENT	7G1J5DA97F	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0713-0536	PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20231201_5f079815-f48b-8b21-2130-7f791d967c9a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE	58-33-3	PROMETHAZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992441	promethazine HCl 12.5 MG Rectal Suppository	PSN	5f079815-f48b-8b21-2130-7f791d967c9a	7
992454	promethazine HCl 25 MG Rectal Suppository	PSN	5f079815-f48b-8b21-2130-7f791d967c9a	7
992445	PROMETHEGAN 12.5 MG Rectal Suppository	PSN	5f079815-f48b-8b21-2130-7f791d967c9a	7
992459	PROMETHEGAN 25 MG Rectal Suppository	PSN	5f079815-f48b-8b21-2130-7f791d967c9a	7
992445	promethazine hydrochloride 12.5 MG Rectal Suppository [Promethegan]	SBD	5f079815-f48b-8b21-2130-7f791d967c9a	7
992459	promethazine hydrochloride 25 MG Rectal Suppository [Promethegan]	SBD	5f079815-f48b-8b21-2130-7f791d967c9a	7
992441	promethazine hydrochloride 12.5 MG Rectal Suppository	SCD	5f079815-f48b-8b21-2130-7f791d967c9a	7
992454	promethazine hydrochloride 25 MG Rectal Suppository	SCD	5f079815-f48b-8b21-2130-7f791d967c9a	7
992445	Promethegan 12.5 MG Rectal Suppository	SY	5f079815-f48b-8b21-2130-7f791d967c9a	7
992459	Promethegan 25 MG Rectal Suppository	SY	5f079815-f48b-8b21-2130-7f791d967c9a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0713-0536-10	00713053610	1000 SUPPOSITORY in 1 BOX (0713-0536-10)	1000 suppository	2004-02-28	0000-00-00	No	No	Current
0713-0536-12	00713053612	12 SUPPOSITORY in 1 BOX (0713-0536-12)	12 suppository	2004-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP Rx Only	Cosette Pharmaceuticals, Inc. \| Cosette Pharmaceuticals NC Laboratories, LLC	2023-11-30	HUMAN PRESCRIPTION DRUG LABEL	7
PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP Rx Only	A-S Medication Solutions	2017-11-28	HUMAN PRESCRIPTION DRUG LABEL	4