Home NDC 31722-040 Promethazine Hydrochloride
Product NDC 31722-040
11-digit product format 317220040
Labeler code 31722
Product ID 31722-040_ecb3a4da-a4fc-7803-e053-2a95a90a0f3f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride
Dosage form SUPPOSITORY
Route RECTAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA216446
Marketing category ANDA
Marketing start 2022-11-02
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 43 .
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 A216446-001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 A216446-002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02
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 2 · 54 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 2026-09-14 22:38:34 2026-08 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216446-001 PROMETHAZINE HYDROCHLORIDE 12.5MG SUPPOSITORY / RECTAL AB 2022-11-02 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216446-002 PROMETHAZINE HYDROCHLORIDE 25MG SUPPOSITORY / RECTAL AB 2022-11-02 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
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 Promethazine Hydrochloride
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992441 Internal RxNorm lookup 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 31722-040-31 Promethazine Hydrochloride 6 in 1 BLISTER PACK SUPPOSITORY 6 1 31722-040-31 Promethazine Hydrochloride 2 in 1 CARTON SUPPOSITORY 2 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-040 PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC, 2 package rows 20221105_ba7d9e82-9b13-4607-b2f9-25e575b8c73b.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.
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 31722-040-31 31722004031 2 BLISTER PACK in 1 CARTON (31722-040-31) / 6 SUPPOSITORY in 1 BLISTER PACK 2 blister pack 2022-11-02 0000-00-00 No No Current