NDC codes

FDA NDC Directory
Product NDC (as listed)0046-1100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00046-1100Add 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
0046-1100-91000461100911 BOTTLE in 1 CARTON (0046-1100-91) / 1000 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 1, 2006
0046-1100-52000461100521 BLISTER PACK in 1 CARTON (0046-1100-52) / 5 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 11, 2019
0046-1100-8100046110081100 TABLET, FILM COATED in 1 BOTTLE (0046-1100-81)Marketed from Jan 1, 2006

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
Generic name (nonproprietary)
estrogens, conjugated
Active ingredients
Estrogens, Conjugated — .3 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 004782
Marketing start
Listing expires
Other FDA classes
Estrogen Receptor Agonists (Mechanism)Conjugated (USP) (Chemical structure)
Identifiers
Product ID 0046-1100_7b9a0278-b55c-41c5-ba63-c46d05a60918SPL ID 7b9a0278-b55c-41c5-ba63-c46d05a60918SPL set ID 258e1602-a3cf-4ccc-ca80-73dbbfb812ffRxCUI 150840, 197660, 197661, 197662, 202301, 208513, 208949, 310197, 403849, 404550UNII IU5QR144QXUPC 0300461100913, 0300461103815, 0300461101811
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400046110091 followed by a unit qualifier and the quantity

Package 00046-1100-91. 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 is a mixture of estrogens indicated for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) • Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure ( 1.3 ) • Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease ( 1.4 ) • Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) ( 1.5 ) • Prevention of Postmenopausal Osteoporosis ( 1.6 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Sympto…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 004782

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 004782
ProductStrengthForm · routeLabelerProduct NDC
Premarinestrogens, conjugatedEstrogens, Conjugated 1.25 mg/1Tablet, Film coatedOralWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.0046-1104
Premarinestrogens, conjugatedEstrogens, Conjugated .625 mg/1Tablet, Film coatedOralWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.0046-1102
Premarinestrogens, conjugatedEstrogens, Conjugated .3 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1853
Premarinestrogens, conjugatedEstrogens, Conjugated .9 mg/1Tablet, Film coatedOralWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.0046-1103
Premarinestrogens, conjugatedEstrogens, Conjugated .45 mg/1Tablet, Film coatedOralWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.0046-1101
Conjugated Estrogensestrogens, conjugatedEstrogens, Conjugated .625 mg/1Tablet, Film coatedOralPrasco Laboratories66993-297
Conjugated Estrogensestrogens, conjugatedEstrogens, Conjugated .3 mg/1Tablet, Film coatedOralPrasco Laboratories66993-295
Conjugated Estrogensestrogens, conjugatedEstrogens, Conjugated .45 mg/1Tablet, Film coatedOralPrasco Laboratories66993-296
Conjugated Estrogensestrogens, conjugatedEstrogens, Conjugated .9 mg/1Tablet, Film coatedOralPrasco Laboratories66993-298
Conjugated Estrogensestrogens, conjugatedEstrogens, Conjugated 1.25 mg/1Tablet, Film coatedOralPrasco Laboratories66993-299
Premarinestrogens, conjugatedEstrogens, Conjugated .625 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-0167

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Premarin NDC 0046-1100 | Med-Code