What is NDC 70700-303?

70700-303 is the product NDC for Abigale Lo, Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 tablet, listed with the FDA by Xiromed LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Abigale Lo (Estradiol and norethindrone acetate).

What is the active ingredient?

Estradiol, Norethindrone acetate.

Xiromed LLC, NDC labeler code 70700. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Abigale Lo?

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.

Abigale Lo NDC 70700-303 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70700-303Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70700-0303Add 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 NDC	11-digit (billing)	Package	Copy
70700-303-85	70700030385	3 POUCH in 1 CARTON (70700-303-85) / 1 BLISTER PACK in 1 POUCH (70700-303-84) / 28 TABLET in 1 BLISTER PACKMarketed from Jan 29, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Abigale Lo
Generic name (nonproprietary): estradiol and norethindrone acetate
Active ingredients: Estradiol — .5 mg/1Norethindrone acetate — .1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Xiromed LLCNDC labeler code 70700
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207261
Marketing start: Jan 29, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 70700-303_35d8f763-8f98-f5ea-fae8-1367b638e82cSPL ID 35d8f763-8f98-f5ea-fae8-1367b638e82cSPL set ID df013d36-de10-0607-7e12-95ed43bf7ee9RxCUI 1359123, 1359124, 1359126, 1359127, 2706646, 2706647UNII 9S44LIC7OJ, 4TI98Z838E
Pharmacologic class: Estrogen; Progestin

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

N470700030385 followed by a unit qualifier and the quantity

Package 70700-0303-85. 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 Sep 17, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Abigale and Abigale Lo are indicated for: Abigale and Abigale Lo are an estrogen and progestin combination indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) Limitations of Use: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. Prevention of Postmenopausal Osteoporosis ( 1.3 ) Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70700-303

What is NDC 70700-303?: 70700-303 is the product NDC for Abigale Lo, Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 tablet, listed with the FDA by Xiromed LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Abigale Lo (Estradiol and norethindrone acetate).
What is the active ingredient?: Estradiol, Norethindrone acetate.
Who is the labeler?: Xiromed LLC, NDC labeler code 70700. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Abigale Lo?: 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.

Other NDCs under ANDA 207261

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

FDA NDC Directory listings under ANDA 207261
Product	Strength	Form · route	Labeler	Product NDC
Abigaleestradiol and norethindrone acetate	Estradiol 1 mg/1; Norethindrone acetate .5 mg/1	TabletOral	Xiromed LLC	70700-330

Abigale Lo (Estradiol and norethindrone acetate) NDC 70700-303