Promethazine

Product NDC: 54348-117
Requested package NDC: 54348-117-12
11-digit product format: 543480117
Labeler code: 54348
Product ID: 54348-117_ea92baba-9184-5d68-e053-2a95a90a5e8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROMETHAZINE
Dosage form: TABLET
Route: ORAL
Labeler: PharmPak, Inc.
Application: ANDA040712
Marketing category: ANDA
Marketing start: 2019-07-11
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 25 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040712-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31
A040712-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04
A040712-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040712-001	AB
A040712-002	AB
A040712-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-002	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2006-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040712-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2006-07-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A040712-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040712-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040712-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040712-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040712-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040712-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040712-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040712-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040712-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040712-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040712-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040712-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040712-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040712-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040712-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040712-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040712-001	AB	1	`8072bd15b7f6…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6bcaa89f-5f14-dc45-e053-2a91aa0aac54	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	804e2525-d61f-7bed-e053-2991aa0a5daa	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f93ca67d-362a-473f-8296-2952da77c074	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	KVK-Tech, Inc.	7a137adf-39b7-4b14-80da-c3cac9ad562a	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	d9cb1a44-d646-d9e9-e053-2995a90a24ff	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7e5715cf-056f-4095-e053-2991aa0ad3e5	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	a7b1e8b2-6f20-4096-87c7-cf349ed4f7b9	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b54439a3-1d01-4c5f-8508-731790ae215b	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b96904e7-cc67-4abc-b946-8423f3f897ff	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	2c9a4767-23c4-4a1c-bb4c-2bad1351c270	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712
Promethazine	PROMETHAZINE	PharmPak, Inc.	4f681538-7ac4-484c-9e6d-b571d73b9e0b	2022-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712 ndc (package): 54348-117-12 ndc (product): 54348-117 ndc11 (package): 54348011712
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	29a8b172-1bad-40db-8d73-1fe7fb309cff	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040712 application number: ANDA040712

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	25 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992447	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
4f681538-7ac4-484c-9e6d-b571d73b9e0b	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	SPL version
54348-117-00	Promethazine	1 in 1 BOTTLE	TABLET	1	2
54348-117-00	Promethazine	1 in 1 BOX	TABLET	1	2
54348-117-02	Promethazine	2 in 1 BOTTLE	TABLET	2	2
54348-117-02	Promethazine	1 in 1 BOX	TABLET	1	2
54348-117-03	Promethazine	3 in 1 BOTTLE	TABLET	3	2
54348-117-03	Promethazine	1 in 1 BOX	TABLET	1	2
54348-117-04	Promethazine	4 in 1 BOTTLE	TABLET	4	2
54348-117-04	Promethazine	1 in 1 BOX	TABLET	1	2
54348-117-05	Promethazine	1 in 1 BOX	TABLET	1	2
54348-117-05	Promethazine	5 in 1 BOTTLE	TABLET	5	2
54348-117-06	Promethazine	6 in 1 BOTTLE	TABLET	6	2
54348-117-06	Promethazine	1 in 1 BOX	TABLET	1	2
54348-117-08	Promethazine	8 in 1 BOTTLE	TABLET	8	2
54348-117-08	Promethazine	1 in 1 BOX	TABLET	1	2
54348-117-09	Promethazine	1 in 1 BOX	TABLET	1	2
54348-117-09	Promethazine	9 in 1 BOTTLE	TABLET	9	2
54348-117-10	Promethazine	10 in 1 BOTTLE	TABLET	10	2
54348-117-10	Promethazine	1 in 1 BOX	TABLET	1	2
54348-117-12	Promethazine	12 in 1 BOTTLE	TABLET	12	2
54348-117-12	Promethazine	1 in 1 BOX	TABLET	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54348-117	PROMETHAZINE TABLET [PHARMPAK, INC.]	2	Current NDC, Legacy NDC, 20 package rows	20221011_4f681538-7ac4-484c-9e6d-b571d73b9e0b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE	58-33-3	PROMETHAZINE HYDROCHLORIDE
FF28EJQ494	PROMETHAZINE	60-87-7	PROMETHAZINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992447	promethazine HCl 25 MG Oral Tablet	PSN	4f681538-7ac4-484c-9e6d-b571d73b9e0b	2
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	4f681538-7ac4-484c-9e6d-b571d73b9e0b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54348-117-12	54348011712	1 BOTTLE in 1 BOX (54348-117-12) / 12 TABLET in 1 BOTTLE	1 bottle	2019-07-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE HYDROCHLORIDE TABLETS, USP	PharmPak, Inc.	2022-10-08	HUMAN PRESCRIPTION DRUG LABEL	2