Home NDC 0713-0132 PROMETHEGAN
Product NDC 0713-0132
11-digit product format 007130132
Labeler code 0713
Product ID 0713-0132_0b625ebc-4f41-49d9-e063-6294a90a56ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name promethazine hydrochloride
Dosage form SUPPOSITORY
Route RECTAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA087165
Marketing category ANDA
Marketing start 1987-08-31
Substance PROMETHAZINE HYDROCHLORIDE
Active strength 50 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A087165-001 PROMETHEGAN PROMETHAZINE HYDROCHLORIDE 50MG SUPPOSITORY / RECTAL RS 1987-08-14
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.
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 2026-08-01 22:54:32 2026-06 A087165-001 PROMETHEGAN 50MG SUPPOSITORY / RECTAL RS 1987-08-14 a50c72e98297…
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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base PROMETHEGAN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROMETHAZINE HYDROCHLORIDE 50 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 992478 Internal RxNorm lookup 992481 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 0713-0132-10 PROMETHEGAN 1000 in 1 BOX SUPPOSITORY 1000 7 0713-0132-12 PROMETHEGAN 12 in 1 BOX SUPPOSITORY 12 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Promethazine Hydrochloride ACTIVE INGREDIENT R61ZEH7I1I PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 3 Promethazine Hydrochloride ACTIVE INGREDIENT R61ZEH7I1I PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 3 Promethazine ACTIVE MOIETY FF28EJQ494 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 3 Promethazine ACTIVE MOIETY FF28EJQ494 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 3 Ascorbyl Palmitate INACTIVE INGREDIENT QN83US2B0N PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 3 Ascorbyl palmitate INACTIVE INGREDIENT QN83US2B0N PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 3 Fat, Hard INACTIVE INGREDIENT 8334LX7S21 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 3 Fat, Hard INACTIVE INGREDIENT 8334LX7S21 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 3 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.] 3 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0132 PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20231201_636bb9bc-0cc5-4d6a-85be-6471acf01ffc.zip
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 0713-0132-10 00713013210 1000 SUPPOSITORY in 1 BOX (0713-0132-10) 1000 suppository 1987-08-31 0000-00-00 No No Current 0713-0132-12 00713013212 12 SUPPOSITORY in 1 BOX (0713-0132-12) 12 suppository 1987-08-31 0000-00-00 No No Current