NDC codes

FDA NDC Directory
Product NDC (as listed)0046-0872Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00046-0872Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0046-0872-0400046087204000460872041 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-04) / 4 g in 1 TUBE, WITH APPLICATORMarketed from Nov 1, 1978
0046-0872-2100046087221000460872211 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-21) / 30 g in 1 TUBE, WITH APPLICATORMarketed from Nov 1, 1978

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Premarin VaginalSuffix: Vaginal
Generic name (nonproprietary)
conjugated estrogens
Active ingredients
Estrogens, Conjugated — .625 mg/g
Dosage form
Cream
Route
Vaginal
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020216
Marketing start
Listing expires
Other FDA classes
Estrogen Receptor Agonists (Mechanism)Conjugated (USP) (Chemical structure)
Identifiers
Product ID 0046-0872_94b7195e-3ce2-4e04-a814-9b63add4896eSPL ID 94b7195e-3ce2-4e04-a814-9b63add4896eSPL set ID 96609623-528e-4aba-cabe-7254aed816d5RxCUI 688240, 688242UNII IU5QR144QXUPC 0300460872217
Pharmacologic class
Estrogen

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400046087204 followed by a unit qualifier and the quantity

Package 00046-0872-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

PREMARIN (conjugated estrogens) vaginal cream is a mixture of estrogens indicated for: • Treatment of Atrophic Vaginitis and Kraurosis Vulvae ( 1.1 ) • Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause ( 1.2 ) 1.1 Treatment of Atrophic Vaginitis and Kraurosis Vulvae 1.2 Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0046-0872

What is NDC 0046-0872?
0046-0872 is the product NDC for Premarin Vaginal (conjugated estrogens), Estrogens, Conjugated .625 mg/g cream, listed with the FDA by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Premarin Vaginal (Conjugated estrogens).
What is the active ingredient?
Estrogens, Conjugated.
Who is the labeler?
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., NDC labeler code 0046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Premarin Vaginal?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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