Home NDC 43063-060 Promethazine Hydrochloride
Product NDC 43063-060
11-digit product format 430630060
Labeler code 43063
Product ID 43063-060_41372747-70d1-1b51-e063-6294a90aef1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride
Dosage form SUPPOSITORY
Route RECTAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA040500
Marketing category ANDA
Marketing start 2006-05-17
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040500-001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 A040500-002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040500-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2003-06-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040500-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2003-06-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Promethazine Hydrochloride
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 992454 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43063-060-02 Promethazine Hydrochloride 2 in 1 BOTTLE, PLASTIC SUPPOSITORY 2 18 43063-060-04 Promethazine Hydrochloride 4 in 1 BOTTLE, PLASTIC SUPPOSITORY 4 18 43063-060-06 Promethazine Hydrochloride 6 in 1 BOTTLE, PLASTIC SUPPOSITORY 6 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-060 PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.] 17 Current NDC, Legacy NDC, 3 package rows 20241012_7d766cf7-a21c-4eaf-bbdc-00f2939ef19a.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE A-S Medication Solutions 46b869e2-9305-43ae-bb15-919a6d09b6ff 2025-12-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040500 application number: ANDA040500 Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. 7d766cf7-a21c-4eaf-bbdc-00f2939ef19a 2025-10-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040500 application number: ANDA040500 ndc (product): 43063-060 Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE Asclemed USA, Inc. 1b1cee64-c0b5-4da6-92d0-1769350a5181 2025-06-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040500 application number: ANDA040500 Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE Padagis Israel Pharmaceuticals Ltd 047b9a7c-586b-4635-a63e-2c7ce9ec34e7 2023-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040500 application number: ANDA040500
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43063-060-02 43063006002 2 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-02) 2 suppository 2011-03-28 0000-00-00 No No Current 43063-060-04 43063006004 4 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-04) 4 suppository 2011-03-28 0000-00-00 No No Current 43063-060-06 43063006006 6 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-06) 6 suppository 2011-03-28 0000-00-00 No No Current